cat8 penumbra catheter

CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Do not use kinked or damaged devices. As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. Lightning comes packaged with the Indigo CAT7 or CAT12. 1. Use prior to the Use By date. Penumbra, Inc. One Penumbra Place. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. This website is intended for US audience only. Possible complications include, but are not limited to, the following: Precautions A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 2019;140:e774-e801. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Tareq Kass-Hout. Mechanical Thrombectomy. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. This content is not intended to offer professional medical advice. CAT7 and CAT12 are the next generation of the Indigo System catheters. Contraindications The CAT family of catheters is the foundation of Penumbra's Indigo system. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. SVG occlusions can be challenging to resolve using traditional treatment modalities. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. UMassMemorial University Campus This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Use only water-based solvents for cleaning. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. J Am Coll Cardiol. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Do not use open or damaged packages. Do not use kinked or damaged devices. The penumbra cat8 indigo system (cat8) was kinked approximately 4. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 2: Add Smidt Heart institute N Engl J Med. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. In 2014, Penumbra broke into the peripheral thrombectomy space with the release of the first Indigo System catheters, the 5-F CAT5 catheter and the 3-F CAT3 catheter (Penumbra, Inc.). The CAT familyof catheters is the foundation of Penumbras Indigo System. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The Indigo Aspiration System is contraindicated in: The canister is intended for single use only. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Penumbra ENGINE Intended Use The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Use prior to the Use By date. Figure 1. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. PENUMBRA ENGINE Intended Use allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. She was in a rehab facility prior to this new event recovering from her CVA. Precautions The device is intended for single use only. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Warnings Otherwise, this could result in degradation of the performance of this equipment. Potential Adverse Events Circulation. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. function gtag(){dataLayer.push(arguments);} Do not use kinked or damaged devices. Use prior to the Use By date. The pulmonary capillary wedge pressure is 10 mmHg. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The Indigo Separator 4 is not intended for use as a guidewire. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). After one pass with CAT RX, the initial occlusion was removed. Latest System Designed for Single Session Arterial Thrombus Removal News Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Contraindications The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. No modification of this equipment is allowed. Possible complications include, but are not limited to, the following: Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Orange, California No modification of this equipment is allowed. Final angiogram showing resolution of extensive thrombus burden. Suhail Dohad, MD, FACC The product-specific content of this website is intended for use by healthcare professionals only. If the cause cannot be determined, withdraw the device or system as a unit. left-arrow As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Return all damaged devices and packaging to the manufacturer/ distributor. The combination of computer- aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Copyright 2022 Penumbra, Inc. All rights reserved. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Penumbra ENGINE Intended Use Indication For Use To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Distal emboli causing PDA occlusion after manual aspiration. Do not re-infuse blood or fluid from the canister back into the patient. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. The cat8 was kinked approximately 69. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. With automatic valve control, Lightning can help the physician focus on optimising thrombus removal procedures. Return all damaged devices and packaging to the manufacturer/distributor. Giri J, Sista AK, Weinberg J, et al. The treatment of arterial and venous thrombus is challenging. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. 0, 23. Categories. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). These types of burns heal withing 5 or 6 days without permanent scarring. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 2. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Copyright 2023 Penumbra, Inc. All rights reserved. It will reduce the service life of the PENUMBRA ENGINE. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. Learn more about Lightning. CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. The procedure can be performed quickly,1 which is important for symptomatic patients. Medical Director, Aortic Disease and Ischemic Limb Disease Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Do not resterilize or reuse. Control angiography immediately after thrombectomy demonstrated restored patency . Mechanical thrombectomy was performed. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Bradenton Cardiology Center/Manatee Memorial Hospital A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. To prevent fire or shock hazard, use a replacement power cord of equal rating. Use prior to the Use By date. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the Penumbra ENGINE as they can interfere with and result in degradation of the performance of the equipment. The INDIGO SEPARATOR 4 is not intended for use as a guidewire. Do not use in an oxygen rich environment. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Warnings The Indigo System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Do not resterilize or reuse. The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Figure 2. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Computer-Aided Aspiration comes packaged with CAT7 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Otherwise, this could result in degradation of the performance of this equipment. As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Indigo System CAT RX tracking through the distal posterior tibial artery. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. waqas.qureshi@umassmemorial.org Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The system uses Penumbra's RED reperfusion catheters. We have found the trackability of CAT RX to be easily navigable for hard-to-reach distal vessels. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Hemoglobin and hematorcrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. $450.00) Model #: CAT8TORQ85 OEM: Penumbra System Expiration Date: 2022 Size: 8Fr x 85cm . Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . The CAT family of catheters is the foundation of Penumbra's Indigo system. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. . Do not use kinked or damaged devices. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. If repositioning of the Indigo CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. INDIGO Aspiration System Indication for Use The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Initial angiography revealed an occlusion of the distal RCA. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. Equipment is not safe for MR use. Figure 3. Randomized trial of primary PCI with or without routine manual thrombectomy. Warnings/Precautions In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Use prior to the Use By date. INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Potential Adverse Events All Rights Reserved Privacy Policy, With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; Suhail Dohad, MD, FACC. N Engl J Med. 3. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems The INDIGO SEPARATOR is not intended for use as a guidewire. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. The complaint indicated that the cat8 was kinked during the procedure. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Indigo Separator 4 is intended to be used with Indigo CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. Indigo System Intended Use These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. Copyright 2022 Penumbra, Inc. All rights reserved. 22. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. The CAT family of catheters is the foundation of Penumbra's Indigo System. Initial angiogram showing high thrombus burden in the RCA. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Otherwise, this could result in degradation of the performance of this equipment. Copyright 2023 Penumbra, Inc. All rights reserved. gtag('js', new Date()); University of Massachusetts Medical School Further evaluation of the returned device revealed kinks in the catheter shaft. function gtag(){dataLayer.push(arguments);} gus.theodos@bjc.org; @gtheodosmd Get Penumbra Cat 8 in Secunderabad, Hyderabad, Telangana at best price by Zephyr Technologies. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Do not use open or damaged packages. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. This website is intended for US audience only. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). 2015;372:1389-1398. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. 2017;377:2240-2252. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Catheters & Separators. The median aspiration time with CAT RX was 35 seconds, with no incidence of stroke within 30 days (Figure 2).3. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of LIGHTNING Aspiration Tubing. The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. The device is intended for single use only. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The procedure was completed with the same catheter. Equipment is not safe for MR use. Worcester, Massachusetts Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; hemoptysis; respiratory failure; thromboembolic events.

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