BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24619986 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05459
    Event Type
    Death
    Date Received
    March 17, 2026
    Date of Event
    November 8, 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
    OR, 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

    H6: OMITTED A1414 AND ADDED A24.

    Additional Manufacturer Narrative · 0

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. INVESTIGATION SUMMARY: PPAE (CARDIAC ARREST): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    A 50-YEAR-OLD FEMALE PATIENT WITH MULTIPLE PRE-EXISTING COMORBIDITIES WAS TRANSFERRED FROM A SMALLER HOSPITAL FOR A HIGH-RISK PCI PROCEDURE IN CARDIOGENIC SHOCK (SCAI STAGE D). DUE TO POOR VASCULAR STATUS, THE CLINICAL TEAM DECIDED TO IMPLANT AN IMPELLA 5.5 FOR HEMODYNAMIC SUPPORT. DURING SUPPORT, ISSUES WITH THE PURGE CASSETTE OCCURRED BUT WERE RESOLVED THROUGH CASSETTE EXCHANGE. THEY TRIED TO DRAIN THE PURGE TO SEE IF THAT WORKED AND IT DID NOT SO THEN TRIED ANOTHER CONSOLE AND STILL NO LUCK. THEN JUST GOT A NEW CASSETTE AND THAT WORKED. BEFORE THE PLANNED PCI COULD BE INITIATED, THE PATIENT DEVELOPED MALIGNANT VENTRICULAR TACHYCARDIA. ADVANCED RESUSCITATION MEASURES (CPR) WERE PERFORMED; HOWEVER, THE PATIENT DID NOT RECOVER AND WAS PRONOUNCED DECEASED. BASED ON THE AVAILABLE INFORMATION, THE FATAL OUTCOME IS CONSIDERED UNLIKELY TO BE DIRECTLY CAUSED BY THE IMPELLA 5.5 DEVICE. NEVERTHELESS, THE EVENT IS BEING REPORTED CONSERVATIVELY DUE TO THE PATIENT¿S DEATH. ENGINEERING ASSESSMENT BY (B)(6). DURING IMPELLA 5.5 SUPPORT, A PURGE CASSETTE WOULD NOT COMPLETE THE DE-AIRING PROCEDURE. AFTER TROUBLESHOOTING WITH AN ADDITIONAL CONSOLE, THE PURGE CASSETTE WAS EXCHANGED FOR A NEW CASSETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109166 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026738774 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1