BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24570886 · Received March 11, 2026

    Report

    Report Number
    1220648-2026-05062
    Event Type
    Death
    Date Received
    March 11, 2026
    Date of Event
    December 22, 2025
    Report Date
    May 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    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

    UPDATED INFORMATION: D4. SERIAL NUMBER UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION). UPON REVIEW, IT WAS IDENTIFIED THAT THE ADDITIONAL INFORMATION HAS BEEN ADDED TO THIS REPORT.

    Additional Manufacturer Narrative · 0

    ADDED: D10 (CONCOMITANT). PPAE (HEMODYNAMIC INSTABILITY/MAJOR. BLEED/INFECTION/THROMBOCYTOPENIA/FEVER/HYPOTENSION/STROKE): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 63-YEAR-OLD MALE PATIENT WITH MULTIPLE COMORBIDITIES, INCLUDING HYPERTENSION, HYPERLIPIDEMIA, TYPE 2 DIABETES MELLITUS, PRIOR CEREBROVASCULAR ACCIDENT, AND SEVERE MITRAL REGURGITATION STATUS POST MITRAL VALVE REPLACEMENT, INITIALLY PRESENTED AFTER A VENTRICULAR TACHYCARDIA ARREST AND PROGRESSED INTO CARDIOGENIC SHOCK. HE UNDERWENT VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION CANNULATION AND SEVERAL ABDOMINAL AND VASCULAR PROCEDURES BEFORE THE IMPELLA DEVICE WAS IMPLANTED AS PART OF ONGOING MANAGEMENT. DURING IMPELLA SUPPORT, THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING REQUIRING ANTICOAGULATION ADJUSTMENT, EXTRACORPOREAL MEMBRANE OXYGENATION DECANNULATION, THROMBOCYTOPENIA, REPEAT GASTROINTESTINAL EVALUATIONS, AND MULTIPLE ALARMS RELATED TO PURGE FLOW AND DEVICE POSITIONING. HE LATER REQUIRED INCREASED INOTROPIC THERAPY AND ADDITIONAL GASTROINTESTINAL SURGERY. OVER SUBSEQUENT WEEKS, HE SHOWED GRADUAL CLINICAL DETERIORATION. ON THE SIXTIETH DAY, HE RECEIVED BLOOD CULTURES AND A BLOOD TRANSFUSION, AND LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION WAS DEFERRED DUE TO FEVER AND THE NEED FOR PELVIC EXPLORATION. ON THE EIGHTIETH DAY OF SUPPORT, THE PATIENT SUFFERED A MASSIVE STROKE, AND LIFE SUSTAINING CARE WAS WITHDRAWN THE FOLLOWING DAY DUE TO PROGRESSIVE DECLINE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES NO INTERVENTIONS WERE PERFORMED, AND MULTIPLE CT SCANS WERE OBTAINED. HEPARIN WAS HELD. THE DEVICE IS NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469340 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026717608 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1