BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA

    MDR report key: 25084341 · Received May 5, 2026

    Report

    Report Number
    1220648-2026-07514
    Event Type
    Injury
    Date Received
    May 5, 2026
    Date of Event
    April 28, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PDI (PERIPHERAL ARTERIAL ISCHEMIA/THROMBOEMBOLISM) : THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    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

    CLINICAL NARRATIVE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 65-YEAR-OLD MALE PATIENT WHO HAD BEEN ADMITTED IN WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. IN ADDITION TO THE CP SUPPORT THE PATIENT WAS ON THE EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO). THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. AFTER 6 DAYS OF SUPPORT THE TEAM EXPLANTED THE CP DUE TO LIMB ISCHEMIA. THE PATIENT REMAINED ON THE ECMO. WHEN EXPLANTED THE CP WAS SEEN TO HAVE THROMBOTIC MATERIAL ATTACHED AND THE PATIENT WAS SCHEDULED FOR SURGICAL INTERVENTION, WHICH WAS PERFORMED AS THE SURGERY WAS DEEMED NECESSARY BY THE MEDICAL TEAM. THE PATIENT HAS SURVIVED. ISCHEMIA MAY BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155587 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026755225 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1