BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 21724337 · Received March 28, 2025

    Report

    Report Number
    1220648-2025-27066
    Event Type
    Death
    Date Received
    March 28, 2025
    Date of Event
    March 3, 2025
    Report Date
    April 9, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF LIMB ISCHEMIA HAS BEEN COMPLETED. THE IMPELLA DEVICE WAS NOT RETURNED FOR EVALUATION. AS ALL THE NECESSARY INFORMATION WAS NOT PROVIDED, THE ROOT CAUSE OF THE LIMB ISCHEMIA WAS NOT DETERMINED. B.2 INTERVENTION WAS INCORRECTLY REPORTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066. B.7 ADDED INFORMATION AS IT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066. E.1 REVISED US PHONE NUMBER AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066. ADDED FAX NUMBER AS IT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066. E.4 SHOULD HAVE BEEN LEFT BLANK ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066 AS IT IS UNKNOWN IF THE INITIAL REPORTER ALSO SENT THE REPORT TO THE FOOD AND DRUG ADMINISTRATION. G.1 ADDED REPORTING CONTACT FACILITY NAME AND FAX NUMBER AS THEY WERE INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066. H.6 CODE 925 WAS REPORTED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27066 AND A NEW CODE WAS ADDED.

    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 CP WITH SMART ASSIST SYSTEM 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)."

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED 87-YEAR-OLD MALE PATIENT HAD NO DEPLORABLE PULSE IN THEIR RIGHT LEG FOLLOWING IMPELLA CP IMPLANT. THE PATIENT'S LEG WAS COLD TO THE TOUCH AT THE TIME OF THE OBSERVATION. THE PATIENT WAS MONITORED FOR TWO DAYS ON SUPPORT, AT WHICH POINT THE FAMILY DECIDED TO WITHDRAW CARE. THE PATIENT PASSED AWAY. THERE IS NOT ENOUGH EVIDENCE TO DISASSOCIATE THE PATIENT'S PASSING AND THE USE OF THE IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661860 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026619102 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Death| R