BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5

    MDR report key: 21552804 · Received March 7, 2025

    Report

    Report Number
    1220648-2025-26583
    Event Type
    Death
    Date Received
    March 7, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 7, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012453
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WILL NOT BE RECEIVED FROM THE CUSTOMER. THEREFORE, INVESTIGATION OF THE DEVICE IS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THE INSTRUCTIONS FOR USE FOR THE IMPELLA 5.5 WITH SMART ASSIST FOR USE DURING CARDIOGENIC SHOCK STATES THE FOLLOWING: SECTION: POTENTIAL ADVERSE EVENTS (UNITED STATES) ¿ACUTE RENAL DYSFUNCTION, AORTIC VALVE INJURY, BLEEDING, CARDIOGENIC SHOCK, CEREBRAL VASCULAR ACCIDENT/STROKE, DEATH, HEMOLYSIS, LIMB ISCHEMIA, MYOCARDIAL INFARCTION, RENAL FAILURE, THROMBOCYTOPENIA AND CARDIAC OR VASCULAR INJURY (INCLUDING VENTRICULAR PERFORATION)¿ THIS COMPLAINT IS FOR ESCALATION TO THE IMPELLA 5.5 DEVICE FROM IMPELLA CP DEVICE USED IN THE 1220648-2025-26536.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF STROKE/CVA HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT ADDITIONAL CLINICAL DETAILS, THE ROOT CAUSE OF THE REPORTED ISSUES COULD NOT BE DETERMINED. B2 SELECTION REQUIRING INTERVENTION WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26583 B3 DATE OF EVENT WAS ERRONEOUSLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26583. E4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26583 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G1 REPORTING CONTACT FACILITY NAME AND FAX NUMBER WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26583. G2 REPORT SOURCE; FOREIGN WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26583.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 64 YEAR OLD FEMALE PATIENT ON AN IMPELLA 5.5 PUMP FOR ESCALATION OF THERAPY AND THE REQUIREMENT FOR LONG TERM THERAPY. THE PATIENT'S HEART FUNCTION IMPROVED SOME, HOWEVER, THE PATIENT DIED OF CEREBRAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281562 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP-JP 2024417469 00813502012453

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| D