BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25095913 · Received May 6, 2026

    Report

    Report Number
    1220648-2026-07584
    Event Type
    Death
    Date Received
    May 6, 2026
    Date of Event
    April 29, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 56-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. THE PATIENT HAD A CARDIAC HISTORY, THE PATIENT WAS TRANSFERRED INTO THE MEDICAL CENTER FROM THE COMMUNITY WITH KNOWN CARDIAC ARREST AND PRIOR PLACED VA-EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO). UPON ARRIVAL THE PATIENT WAS ACTIVELY UNDERGOING CPR. THE PATIENT HAD THE CP PLACED IN THE CARDIAC CATHETERIZATION LAB WITH ONGOING BLOOD LOSS FROM NOSE AND MOUTH AREA AND HEMATOMA PRIOR TO THE PUMP PLACEMENT. FLOWS WERE LOW ON BOTH THE CP AND ECMO AND TROUBLESHOOTING WAS DONE BY PUMP REPOSITIONING. EVEN AFTER THE CP WAS ADDED TO THE ECMO SUPPORT THE PATIENT WAS HEMODYNAMICALLY UNSTABLE AND WAS GIVEN 10 UNITS OF RED BLOOD CELLS, 6 UNITS OF FRESH FROZEN PLASMA, AND 4 UNITS OF PLATELETS. THE TEAM EVALUATED THE PATIENT WITH ULTRASOUND AND CONSIDERED THE FLUID IN THE ABDOMINAL SPACES WAS SIGNS FOR "THIRD-SPACING". THE TEAM GAVE MEDICAL THERAPY TO ATTEMPT COAGULATION BUT HEMODYNAMICS DID NOT RECOVER. THE FAMILY MADE DECISION TO WITHDRAW CARE AND PATIENT EXPIRED. THE DEATH IS BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE E AND HAD CARE WITHDRAWN WHEN ALL MEASURES WERE TAKEN AND DID NOT IMPROVE HEMODYNAMICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43935 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025578913 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death