BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24413029 · Received February 23, 2026

    Report

    Report Number
    1220648-2026-03745
    Event Type
    Death
    Date Received
    February 23, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: D1 BRAND NAME UPDATED. G1 MFR CONTACT FAX NUMBER ADDED. H6 COMPONENT CODE CHANGED TO G07003. THE INVESTIGATION FOR THE HEMATURIA/STROKE HAS BEEN COMPLETED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    CLINICAL RATIONALE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE LEFT AXILLARY/SUBCLAVIAN ARTERY IN A 74-YEAR-OLD FEMALE PATIENT WITH A PAST MEDICAL HISTORY OF A PRIOR CORONARY ARTERY BYPASS GRAFT (CABG), AND RENAL INSUFFICIENCY, PRESENTING IN CARDIOMYOPATHY, AND IN SCAI STAGE D SHOCK, ON AN INTRA-AORTIC BALLOON PUMP (IABP), ON AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), ON MULTIPLE INOTROPES AND VASOPRESSORS, AND WAS ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), HEMATURIA WAS NOTED. THREE DAYS AFTER IMPLANT, THE PATIENT EXPERIENCED A MASSIVE HEMORRHAGIC STROKE. THE FAMILY ELECTED TO WITHDRAW CARE, AND THE PATIENT EXPIRED ON SUPPORT. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S AND ECMO'S ANTICOAGULATION AND PURGE REQUIREMENTS. CEREBRAL VASCULAR ACCIDENT/STROKE IS LISTED AS A POTENTIAL ADVERSE EVENT, AND CONSISTENT WITH KNOWN DEVICE-RELATED AND PATIENT-RELATED FACTORS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22396 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026677295 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Death