BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24565826 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04974
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    November 29, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    D1 (BRAND NAME) AND D4 (SERIAL) HAS BEEN UPDATED. PPAE (ARRHYTHMIA/MAJOR BLEED): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN 82-YEAR-OLD MALE PATIENT WAS ADMITTED WITH ACUTE MI, CARDIOGENIC SHOCK. AN IMPELLA 5.5 WAS PLACED, AND THE PATIENT UNDERWENT HIGH RISK PERCUTANEOUS CORONARY INTERVENTION. THE IMPELLA WAS ADVANCED DUE TO SOME ECTOPY. POST PROCEDURE, THE PATIENT DEVELOPED A LEFT LUNG HEMOTHORAX REQUIRING CHEST TUBE PLACEMENT. LUNG SURGERY WAS COMPLETED. CARE WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601683 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026774748 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death