BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24585216 · Received March 12, 2026

    Report

    Report Number
    1220648-2026-05180
    Event Type
    Death
    Date Received
    March 12, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A150204 ADDED TO H6. CORRECTED DATA D1 CORRECTED/UPDATED. THE INVESTIGATION IS STILL ONGOING.

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE HEMODYNAMIC INSTABILITY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN. THE CAUSE OF THE FAILURE TO ADVANCE WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN. THE CAUSE OF THE 0.018 KINKING WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS AND NO PRODUCT RETURN.

    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

    CLINICAL REVIEW/RATIONALE: AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 82-YEAR-OLD FEMALE PATIENT WHO HAD BEEN ADMITTED IN WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE D SHOCK. PRIOR TO THE CP PLACEMENT THE PATIENT WAS SUPPORTED BY INOTROPES, VASOPRESSORS, A VENT FOR RESPIRATORY NEEDS, AND CPR. THE UNDERLYING MEDICAL HISTORY WAS NOT SHARED. THE CP WAS BEING INSERTED WHEN THE TEAM DROPPED THE .018 ABIOMED GUIDEWIRE. AS SUCH, THE TEAM HAD TO PLACE THE CP OVER A NON-ABIOMED WIRE, THE COMMAND .018 WIRE, BUT THEY WERE UNABLE TO DELIVER DUE TO KINKING. THE TEAM REMOVED THE PUMP AND REPLACED THE PUMP AND WIRE. THE PATIENT ARRESTED AND EXPIRED ON THE SECOND PUMP. THE DELAY IN SUPPORT INITIATION WAS NOT NOTED TO BE THE CAUSE OF DEATH. THE FAILED DELIVERY WITH KINKING, WILL BE CONSERVATIVELY REPORTED FOR HEMODYNAMIC INSTABILITY DUE TO TEMPORARY HEMODYNAMIC SUPPORT INTERRUPTION/DELAY DURING THE EXCHANGE. THE DEATH IS CONSERVATIVELY BEING REPORTED ALTHOUGH AN UNLIKELY CONTRIBUTING FACTOR TO THE DEATH, AND MORE LIKELY THE PATIENT'S PRESENTING NATIVE CRITICAL CONDITION AS PRESENTED IN SCAI STAGE D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106736 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026768152 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Death