BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 23421076 · Received October 29, 2025

    Report

    Report Number
    1220648-2025-47942
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAJOR BLEED: THE CAUSE OF THE INJURY WAS NOT DETERMINED SINCE PRODUCT WAS NOT RETURNED AND INSUFFICIENT CLINICAL DETAILS PROVIDED. ARRHYTHMIA: THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. DEVICE HISTORY LOT: DEVICE LOT: 1931506. DEVICE HISTORY REVIEW: THE PUMP S/N: (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT AFTER EXPERIENCING A CARDIAC ARREST. THE PATIENT WAS SUPPORTED BY IMPELLA CP DURING A PERCUTANEOUS CORONARY INTERVENTION TO THE RIGHT CORONARY AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES. ON SUPPORT DAY 4, THE PATIENT EXPERIENCED A GASTROINTESTINAL BLEED WHICH HEPARIN WAS WITHHELD TO MANAGE THE BLEEDING. THE FOLLOWING DAY THE PATIENT WAS TRANSFUSED WITH ONE UNIT OF RED BLOOD CELLS, AND IT WAS NOTED THAT THE PATIENT¿S STOOL REMAINED BLACK AND TARRY. IT WAS NOTED THAT ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED, AND A GASTRIC ULCER WAS CONFIRMED AS THE SOURCE OF THE BLEED. ADDITIONALLY, THE PATIENT EXPERIENCED PREMATURE VENTRICULAR CONTRACTIONS AND RECEIVED A BOLUS AND CONTINUOUS INTRAVENOUS INFUSION OF AMIODARONE TO RESOLVE THE ISSUE. THE DEVICE WAS EXPLANTED SUCCESSFULLY AFTER WEANING. THE EXPLANT WAS NOT CONSIDERED PREMATURE AND WAS UNRELATED TO THE REPORTED COMPLICATION. THE PATIENT'S OUTCOME AT THE TIME OF EXPLANT WAS SURVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379649 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026686699 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Life Threatening| R