BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA 5.5 WITH SMARTASSIST S2 SET, US

    MDR report key: 24563373 · Received March 10, 2026

    Report

    Report Number
    1220648-2026-04934
    Event Type
    Death
    Date Received
    March 10, 2026
    Date of Event
    October 27, 2025
    Report Date
    March 19, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: H6 COMPONENT CODE G04105 CHANGED TO G07003. THE INVESTIGATION FOR THE ARRHYTHMIA HAS BEEN COMPLETED. THE ROOT CAUSE OF THE INJURY WAS NOT 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

    72 YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF ISCHEMIC AND NON-ISCHEMIC CARDIOMYOPATHY AND HEART FAILURE WITH RESERVED EJECTION FRACTION, ADMITTED FOR VENTRICULAR TACHYCARDIA. FOLLOWING IMPELLA CP PLACEMENT, RED URINE AND HEMOLYZED LABS WERE NOTED MOST LIKELY DUE TO IMPROPER POSITIONING. REPOSITIONING EFFORTS FAILED DUE TO ANATOMY AND DECISION WAS MADE TO ESCALATE TO 5.5 DUE TO RESOLVE HEMOLYSIS/HEMATURIA, DUE TO PATIENT NEEDING MORE SUPPORT, AND IN PREPARATION FOR VENTRICULAR ABLATION WITH LESS INTERACTION WITH PUMP. HEMATURIA RESOLVED WITH ESCALATION TO 5.5 BUT, PATIENT STILL EXPERIENCED OCCASIONAL VT WITH COUGHING THAT DID NOT AFFECT TREATMENT DECISIONS, AND FINALLY FAMILY DECIDED TO WITHDREW CARE AND PATIENT EXPIRED. THE IMPELLA CP WILL BE CODED AS UNRESOLVED HEMOLYSIS. SINCE THE PATIENT PRESENTED IN VT STORM THE OCCASIONAL VT WOULD QUALIFY FOR PREEXISTING CONDITION. THE DEATH WILL BE CONSERVATIVELY REPORTED TO THE IMPELLA 5.5 BUT IT IS RECOGNIZED THAT IT WAS UNLIKELY RELATED TO THE CAUSE OF DEATH AND WAS MOST LIKELY RELATED TO PATIENTS UNDERLYING CRITICAL CONDITION AND FAMILY ELECTED TO WITHDRAW CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272801 IMPELLA 5.5 WITH SMARTASSIST S2 SET, US TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026693700 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1