BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA CP SMART ASSIST SET, KR

    MDR report key: 24638991 · Received March 19, 2026

    Report

    Report Number
    1220648-2026-05626
    Event Type
    Death
    Date Received
    March 19, 2026
    Date of Event
    February 7, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013368
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ISCHEMIA: THE ROOT CAUSE OF THE ISCHEMIA 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 REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA UNKNOWN ACCESS TO SUPPORT THE PATIENT OF UNKNOWN AGE AND GENDER IN THE (B)(6) FACILITY. THE PATIENT'S MEDICAL HISTORY WAS NOT SHARED. THE PATIENT WAS IN CARDIOGENIC SHOCK SECONDARY TO A ST-ELEVATION MYOCARDIAL INFARCTION. THE CP WAS INSERTED AND THE TEAM PERFORMED PERCUTANEOUS CORONARY INTERVENTION, AFTER WHICH THE IMPELLA WAS REMOVED. POST REMOVAL THE TEAM PERFORMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). WHETHER THE PTA WAS PERFORMED FOR ACUTE LIMB ISCHEMIA OR VESSEL DAMAGE/PERFORATION WAS NOT SHARED. VESSEL DAMAGE AND ISCHEMIA CAN BE INFLUENCED BY PATIENT-SPECIFIC FACTORS SUCH AS SEVERE PERIPHERAL VASCULAR DISEASE, UNDERLYING CRITICAL ILLNESS, HEMODYNAMIC INSTABILITY, AND VASCULAR ACCESS CHARACTERISTICS. THIS PTA FAILED AND THE PATIENT CONDITION DETERIORATED AND SO THE TEAM PLACED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FOR THE PATIENT'S HEMODYNAMIC SUPPORT, THOUGH THE PATIENT EXPIRED 5 DAYS LATER. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698801 IMPELLA CP SMART ASSIST SET, KR TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026802557 00813502013368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death