ABIOMED

Circulatory Support Systems

Impella RP IMP-370 Product Update v2 Feb 2021

Product Update

2 Pages

PRODUCT UPDATE February 2021  Clot Ingestion by Impella RP® after Transition from ECMO  What’s New Routine surveillance of Impella RP catheters inserted immediately after or simultaneous with ECMO explantation have a higher rate of clot ingestion causing hemolysis or pump stop... ailure analysis has shown thrombus ingestion at the pump inlet (believed to originate from the ECMO cannula) and can result in low flow, high pump setting values with accompanying hemolysis as evidenced by elevated pfHb or sudden pump stop... nalysis of these pumps have shown that the clot restricted the movement of the impeller; however, the pumps functioned normally once the thrombus was removed... Recommendations 1... nsertion of RP with the ECMO venous cannula in place should be avoided... n patients with isolated RV failure without hypoxia, with or without left sided hemodynamic support, use Impella RP without first using ECMO if possible... f ECMO is used first (such as patients with cardiac arrest or profound hypoxia), removing the venous cannula prior to insertion of Impella RP is preferred... here have been situations in which an Impella RP suffers a pump stop after ECMO cannula manipulation... f the Impella RP is seen to have ingested clot, do not attempt to remove the clot and reinsert the catheter... otal clot removal cannot be adequately performed without disassembly of the motor housing...  new second pump should be used at no charge to the account as long as your Abiomed rep initiates a complaint... lood Inlet Area Impella RP® Heart Pump  22 Fr Pump Motor  Blood Outlet Area  Catheter Diameter: 11Fr Flow Rate: Greater than 4... L/min*  *Flow rate can vary due to suction or incorrect positioning... ee Instructions for Use for more information... Clinical Support Center 24 hours per day, 7 days a week: 1-­800-­422-­8666 (US) + 49 (0) 180 522 466 33 (EU)  Abiomed, Inc... 2 Cherry Hill Drive, Danvers, MA 01923 USA p: 978-­646-1400 f: 978-­777-8411 marketing@abiomed... m   IMPELLA RP® INDICATION & SAFETY INFORMATION PMA APPROVED INDICATION The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1... m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery... MERGENCY USE AUTHORIZATION The Impella RP System is authorized to be used by healthcare providers (HCP) in the hospital setting for providing temporary right ventricular support for up to 14 days in critical care patients with a body surface area ≥1... m2, for the treatment of acute right heart failure or decompensation caused by complications related to Coronavirus Disease 2019 (COVID‐19), including pulmonary embolism (PE)... he Impella RP has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U... C...  360bbb‐3(b)(1), unless the authorization is terminated or revoked sooner... mportant Risk Information for Impella RP System CONTRAINDICATIONS The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device... echanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve... ural thrombus of the right atrium or vena cava... natomic conditions precluding insertion of the pump... resence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter... OTENTIAL ADVERSE EVENTS The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia... n addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP... isit www... iomed... m/important-safety-information to learn more... Abiomed Clinical Support Center (CSC) can be reached 24/7 at 1-888-422-8666  Clinical Support 24 hours per day, 7 days a week: 1-­800-­422-­8666 (US) IMP-370 v2  To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www... iomed... m/important-safety-information *This bulletin is intended for dissemination of technical information only...
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