BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24607207 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05340
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    December 23, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARDIAC ARREST/HEMODYNAMIC INSTABILITY: THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. HEMOLYSIS/MECHANICAL INTERACTION WITH BLOOD: NO LOGS WERE RETURNED. THE CAUSE OF THE HEMOLYSIS CANNOT BE DETERMINED SINCE NO PRODUCT OR DATA LOGS WERE RETURNED AND INSUFFICIENT CLINICAL DETAILS WERE PROVIDED.

    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

    AN 80-YEAR-OLD FEMALE PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE RECEIVED IMPELLA 5.5 SUPPORT FOR POST-CARDIOTOMY CARDIOGENIC SHOCK. SHE WAS ON AN INTRA-AORTIC BALLOON PUMP AND MECHANICAL VENTILATION PRIOR TO IMPLANTATION. ON THE FIFTH DAY OF SUPPORT, THE PATIENT EXPERIENCED A CARDIAC ARREST AND WAS CANNULATED FOR VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION; PINK-TINGED URINE WAS NOTED, AND ECHOCARDIOGRAPHY CONFIRMED APPROPRIATE IMPELLA POSITIONING. LATER THE SAME DAY, PLASMA-FREE HEMOGLOBIN LEVELS INCREASED, INDICATING HEMOLYSIS, WHICH THE PHYSICIAN ATTRIBUTED PRIMARILY TO EXTRACORPOREAL MEMBRANE OXYGENATION OR THE COMBINED MECHANICAL CIRCULATORY SUPPORT. AFTER FOURTEEN DAYS OF SUPPORT WITH MULTIPLE DEVICES AND MECHANICAL VENTILATION, THE PATIENT SHOWED NO CLINICAL IMPROVEMENT, AND THE TREATING PHYSICIAN ELECTED TO WITHDRAW LIFE-SUSTAINING CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206633 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026704477 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death| R