BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24743507 · Received March 31, 2026

    Report

    Report Number
    1220648-2026-06175
    Event Type
    Death
    Date Received
    March 31, 2026
    Date of Event
    November 6, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW, IT WAS IDENTIFIED THAT THE MANUFACTURER FAX (D3) WAS INADVERTENTLY OMITTED IN ERROR; THE COMPLETE FAX NUMBER HAS NOW BEEN PROVIDED. H6 INVESTIGATION: TYPE, FINDINGS, AND CONCLUSION CODES AND H6 COMPONENT CODES WERE UPDATED ACCORDINGLY BASED ON THE COMPLETED INVESTIGATION. THE CAUSE OF THE MECHANICAL INTERACTION WITH BLOOD AND HEMOLYSIS WAS NOT DETERMINED DUE TO NO PRODUCT RETURNED, INCONCLUSIVE DATA LOG REVIEW, AND INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    D4. SERIAL AND PRIMARY UDI NUMBER CORRECTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED. 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

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY FOR THE 84 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH THE INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D. PRIOR TO THE PUMP DELIVERY THE PATIENT WAS KNOWN TO HAVE HAD A PRIOR CARDIAC ARREST, AND BEEN ON SUPPORT WITH INOTROPES/VASOPRESSORS AND A VENT FOR RESPIRATORY NEEDS. UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE PUMP SUPPORTED TIL FAMILY MADE DECISION TO WITHDRAW CARE AND THE PATIENT EXPIRED. THE TEAM MONTHS LATER REPORTED UPON HEMOLYSIS CONCERNS. IT IS NOT KNOWN IF DIALYSIS OR ANY FURTHER ACTION WAS NEEDED TO CARE FOR ISSUE WITH THIS PATIENT. HEMOLYSIS MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS CRITICAL ILLNESS, UNDERLYING CARDIAC DYSFUNCTION, HEMODYNAMIC INSTABILITY, RENAL FUNCTION, ANTICOAGULATION STATUS, AND POTENTIAL DEVICE POSITION. THE DEATH IS CONSERVATIVELY 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 D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281321 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026756777 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death