BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23794176 · Received December 12, 2025

    Report

    Report Number
    1220648-2025-48973
    Event Type
    Injury
    Date Received
    December 12, 2025
    Date of Event
    November 14, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT INVESTIGATION CLOSURE. INVESTIGATION SUMMARY: PPAE: MAJOR BLEED. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1930021. DEVICE HISTORY REVIEW: THIS PUMP SN (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS NOT BEEN 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.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A 79 YR OLD MALE WAS IMPLANTED WITH A IMPELLA CP FOR SUPPORT DURING HIGH RISK CARDIAC PROCEDURE. IT WAS REPORTED THAT THE HEPARIN WAS HELD DUE TO PERICARDIAL BLEEDING. IMPELLA INCREASE TO P-8. IMPELLA WAS SUCCESSFULLY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703760 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026674973 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention