BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP

    MDR report key: 23407295 · Received October 28, 2025

    Report

    Report Number
    1220648-2025-47887
    Event Type
    Death
    Date Received
    October 28, 2025
    Date of Event
    September 29, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A5 AND A6 ARE UNKNOWN. 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

    B1 (IS REQUIRED INTERVENTION) WAS TICKED. B5 (EVENT DESCRIPTION) WAS UPDATED. H6 (MEDICAL DEVICE PROBLEM CODE) WAS ADDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN IMPELLA CP EXPERIENCED BLEEDING. MULTIPLE BLOOD PRODUCTS WERE TRANSFUSED WITHOUT RESOLUTION. LATER, CARE WAS WITHDRAWN AND THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    PRE-PROCEDURE NARRATIVE: 73 YEAR OLD MALE HISTORY OF AFIB, SEVERE MR. WAS TAKEN TO OPERATING ROOM (OR) TODAY FOR MVR AND TVR. POST-PROCEDURE NARRATIVE: PATIENT WAS TAKEN TO OR FOR MVR AND TVR. AFTER VALVE REPAIR PATIENT HEART HAD NO CONTRACTILITY. DECISION MADE TO TRANSITION PATIENT OFF PUMP TO VA ECMO WITH IMPELLA CP FOR UNLOADING. IMPELLA CP PREPPED AND INSERTED PER IFU VIA THE LFA. PEEL AWAY SHEATH REMOVED AND REPOSITIONING SHEATH ADVANCED. HAD BLEEDING COMPLICATIONS FROM SURGERY SO MULTIPLE BLOOD PRODUCTS GIVEN BUT UNABLE TO OBTAIN GOOD FLOWS ON VA ECMO. TRANSFERRED TO ICU IN CRITICAL CONDITION. SURGEON CALLING FAMILY TO DISCUSS GOALS OF CARE. CASE WRAP-UP: DECISION MADE TO WITHDRAW CARE, IMPELLA AND ECMO STOPPED, PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904643 IMPELLA CP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA CP 2026700164 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death