BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23889629 · Received December 24, 2025

    Report

    Report Number
    1220648-2025-49364
    Event Type
    Death
    Date Received
    December 24, 2025
    Date of Event
    December 11, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PPAE (ISCHEMIA): IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT- 1980833. DEVICE HISTORY BATCH SUBCOMPONENT LOT- N/A. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT WAS IMPLANTED WITH AN IMPELLA CP VIA THE LEFT FEMORAL ARTERY FOR MECHANICAL CIRCULATORY SUPPORT. ON THE FIRST DAY OF IMPELLA SUPPORT, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE FLOW DISTAL TO THE PATIENT¿S LEFT FOOT. THE PATIENT WAS TAKEN TO THE CARDIAC CATHETERIZATION LABORATORY FOR A FEMORAL-TO-FEMORAL BYPASS, WHICH SUCCESSFULLY RESTORED FLOW TO THE PATIENT¿S LEFT FOOT. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT EXPIRED DURING IMPELLA SUPPORT. IT WAS NOTED THAT THE CAUSE OF DEATH WAS UNKNOWN, AND THE PHYSICIAN DID NOT BELIEVE THE DEATH WAS IMPELLA RELATED. THE PHYSICIAN STATED HE BELIEVED THE CAUSE OF DEATH WAS DUE TO OTHER ISSUES AND THAT THE FAMILY CHOSE TO WITHDRAW CARE OF THE PATIENT. ADDITIONAL CLINICAL DETAILS, INCLUDING PERIOPERATIVE COURSE AND CONTRIBUTING FACTORS, WERE UNAVAILABLE AT THE TIME OF REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919473 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026760961 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female Death