BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24968800 · Received April 23, 2026

    Report

    Report Number
    1220648-2026-07074
    Event Type
    Death
    Date Received
    April 23, 2026
    Date of Event
    April 17, 2026
    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
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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

    CORRECTED INFORMATION WAS PROVIDED IN B2, D3, AND E1. UPON REVIEW, IT WAS IDENTIFIED THAT THESE WERE INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4. UPON REVIEW, THE SERIAL AND PRIMARY UDI NUMBER HAVE BEEN UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE RIGHT FEMORAL ARTERY TO SUPPORT THE 79 YEAR OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. PRIOR TO THE PUMP PLACEMENT THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE PATIENT HAS A HISTORY OF CLAUDICATION, BUT OTHER UNDERLYING MEDICAL HISTORY WAS NOT SHARED. ON THE DAY OF IMPLANT THERE WAS HEMATURIA OBSERVED. THEY ASSESSED PUMP POSITION AND ADJUSTED THE PUMP'S P LEVEL FROM 9 DOWN TO 6. THE TEAM WAS AWARE THAT THE FOLEY INSERTION WAS DIFFICULT WHICH COULD HAVE CONTRIBUTED TO THE HEMATURIA. IN ADDITION, THE TEAM OBSERVED THAT THERE WAS LIMB PAIN AND NUMBNESS. TO ASSESS FOR LIMB ISCHEMIA THEY PERFORMED ULTRASOUND AND HAD THE VASCULAR SURGERY TEAM ASSESS THE LIMB'S FLOW. DUE TO DIFFICULTY WITH IMAGING ANY FLOW AROUND THE PUMP, AND THE NEED FOR DOPPLER TO ASSESS PULSES, THE TEAM MADE DECISION TO EXPLANT THE PUMP AND THEN IF DEEMED NECESSARY HAVE VASCULAR PERFORM THROMBECTOMY AND POSSIBLE AMPUTATION IF NECESSARY FOR THE NUMB FOOT. THE PUMP WAS EXPLANTED, AND THE PATIENT SUFFERED FROM ATRIAL FIBRILLATION AND HYPOTENSION. THE DECISION WAS MADE TO WITHDRAW CARE AND PATIENT EXPIRED BEFORE ANY INTERVENTION COULD BE PERFORMED FOR THE ISCHEMIC IMPELLA ACCESSED LEG. 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
    615233 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027854646 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1