BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24348308 · Received February 16, 2026

    Report

    Report Number
    1220648-2026-03280
    Event Type
    Death
    Date Received
    February 16, 2026
    Date of Event
    April 17, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D4 (SERIAL). 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

    PPAE: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER, THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    A SIXTY-SEVEN-YEAR-OLD MALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE AND VALVULAR DYSFUNCTION RECEIVED AN IMPELLA CP DEVICE ALONG WITH VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION FOR MANAGEMENT OF POST-CARDIOTOMY CARDIOGENIC SHOCK CONSISTENT WITH STAGE D CLASSIFICATION. PRIOR TO IMPELLA CP PLACEMENT, THE PATIENT EXPERIENCED MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION THAT REQUIRED DEFIBRILLATION, AND HE WAS RECEIVING MULTIPLE INOTROPIC MEDICATIONS AND MECHANICAL VENTILATION. DURING INSERTION OF THE INITIAL IMPELLA CP DEVICE, THE PUMP WAS FOUND TO BE MALFUNCTIONING WHEN CONNECTED TO THE WHITE CONNECTOR CABLE; THE DEVICE WAS NOT IMPLANTED AND WAS IMMEDIATELY REPLACED WITH A SECOND IMPELLA CP DEVICE, WHICH WAS SUCCESSFULLY INSERTED. TWO DAYS AFTER IMPELLA CP PLACEMENT, THE PATIENT WAS ESCALATED TO AN IMPELLA 5.5 DEVICE TO PROVIDE INCREASED HEMODYNAMIC SUPPORT AND FACILITATE WEANING FROM EXTRACORPOREAL MEMBRANE OXYGENATION. THE PATIENT¿S CLINICAL CONDITION SUBSEQUENTLY CONTINUED TO DETERIORATE, AND THE FAMILY ELECTED TO WITHDRAW CARE AFTER A DAY OF 5.5 AND ECMO SUPPORT. DEATH WAS CONSERVATIVELY CODED TO THE IMPELLA 5.5 WHILE MOST LIKELY TO BE CAUSED BY THE UNDERLYING DISEASE AND UNRELATED TO IMPELLA. DEATH WAS CONSERVATIVELY CODED TO THE IMPELLA 5.5 WHILE MOST LIKELY TO BE CAUSED BY THE UNDERLYING DISEASE AND UNRELATED TO IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567554 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US 2025585330 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1