BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24642116 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05673
    Event Type
    Death
    Date Received
    March 19, 2026
    Date of Event
    November 27, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. THE CAUSE OF THE HEMOLYSIS CANNOT BE DETERMINED SINCE NO PRODUCT OR DATA LOGS WERE RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED. THE CAUSE OF THE BLEED WAS MOST LIKELY USE ISSUE RELATED DUE TO ANTICOAGULATION MANAGEMENT SINCE STOPPING THE HEPARIN RESOLVED THE BLEED.

    Additional Manufacturer Narrative · 0

    D1: BRAND NAME CORRECTED. D4: SERIAL CORRECTED.

    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.

    Description of Event or Problem · 0

    A 69-YEAR-OLD MALE PATIENT WAS ADMITTED WITH ACUTE DECOMPENSATED HEART FAILURE. AN IMPELLA 5.5 WAS PLACED AND THE PATIENT WAS WORKED UP FOR POSSIBLE DURABLE VENTRICULAR ASSIST DEVICE. THE PATIENT HAD ISSUES WITH VASOPLEGIA WHICH REQUIRED PRESSOR SUPPORT. OOZING WAS NOTED AT THE IMPELLA INSERTION SITE, SO ANTICOAGULATION WAS HELD. THE FIELD REPRESENTATIVE RESPONDED THAT HEPARIN WAS HELD FOR FOUR HOURS AND PRESSURE WAS APPLIED. HEMOLYSIS WAS NOTED INITIALLY, HOWEVER, RESOLVED ON ITS OWN. THE PUMP WAS NOTED TO BE IN GOOD POSITION. CREATININE STARTED TRENDING UP. THE FAMILY OPTED TO MAKE PATIENT COMFORT CARE ONLY, AND THE IMPELLA WAS REMOVED AND CARE WAS WITHDRAWN. THE IMPELLA IS CONSERVATIVELY BEING REPORTED FOR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252112 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026653709 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1