BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24697570 · Received March 26, 2026

    Report

    Report Number
    1220648-2026-05937
    Event Type
    Death
    Date Received
    March 26, 2026
    Date of Event
    March 18, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502013474
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. 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 CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 61-YEAR-OLD FEMALE PATIENT PRESENTING WITH MITRAL REGURGITATION (MR), SCAI SHOCK STAGE E. THE PATIENT¿S COMORBIDITIES WERE UNKNOWN. THE CARE TEAM REPORTED NO PULSE IN THE LEFT FOOT WHERE THE IMPELLA WAS INSERTED. THE PEEL-AWAY SHEATH REMAINED IN PLACE, AND A RETROGRADE SHEATH WAS CONNECTED TO THE PEEL-AWAY SHEATH. ANOTHER CONTRIBUTING FACTOR WAS THE PRESENCE OF VERY SMALL VESSELS IN THE SETTING OF VASOPRESSOR THERAPY AND ECMO SUPPORT. CARE WAS LATER WITHDRAWN, AND THE PATIENT EXPIRED. THE ISCHEMIA IS CONSISTENT WITH ACCESS-RELATED COMPLICATIONS AND MAY BE INFLUENCED BY SEVERE HEMODYNAMIC INSTABILITY, VASOPRESSOR-INDUCED VASOCONSTRICTION, ECMO-RELATED CIRCULATORY FACTORS, AND SMALL-CALIBER PERIPHERAL VESSELS. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, THE DEATH IS MOST LIKELY ATTRIBUTABLE TO THE SEVERITY OF THE UNDERLYING CARDIOGENIC SHOCK AND CRITICAL ILLNESS ASSOCIATED WITH SCAI SHOCK STAGE E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57993 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 S9652838 00813502013474

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Death