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. Failure 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. Analysis 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. Insertion of RP with the ECMO venous cannula in place should be avoided. 2. In patients with isolated RV failure without hypoxia, with or without left sided hemodynamic support, use Impella RP without first using ECMO if possible. 3. If 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. There have been situations in which an Impella RP suffers a pump stop after ECMO cannula manipulation. If the Impella RP is seen to have ingested clot, do not attempt to remove the clot and reinsert the catheter. Total clot removal cannot be adequately performed without disassembly of the motor housing. A new second pump should be used at no charge to the account as long as your Abiomed rep initiates a complaint. Blood Inlet Area Impella RP® Heart Pump
22 Fr Pump Motor
Blood Outlet Area
Catheter Diameter: 11Fr Flow Rate: Greater than 4.0 L/min*
*Flow rate can vary due to suction or incorrect positioning. See 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. 22 Cherry Hill Drive, Danvers, MA 01923 USA p: 978-646-1400 f: 978-777-8411 [email protected]
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 ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open‐heart surgery. EMERGENCY 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 ≥1.5 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). The 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.S.C. § 360bbb‐3(b)(1), unless the authorization is terminated or revoked sooner. Important 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. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence 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. POTENTIAL 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. In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP. Visit www.abiomed.com/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.abiomed.com/important-safety-information *This bulletin is intended for dissemination of technical information only.