BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24780347 · Received April 3, 2026

    Report

    Report Number
    1220648-2026-06383
    Event Type
    Death
    Date Received
    April 3, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 3, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. THE CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP DEVICE WAS INSERTED VIA THE LEFT FEMORAL ARTERY IN A 74-YEAR-OLD MALE PATIENT PRESENTING WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED BY CARDIOGENIC SHOCK (AMI/CGS), SCAI SHOCK STAGE E, WITH A HISTORY OF PRIOR CORONARY ARTERY BYPASS GRAFTING, KNOWN CORONARY ARTERY DISEASE, DIABETES MELLITUS, AND RENAL INSUFFICIENCY. DESPITE IMPELLA SUPPORT, THE PATIENT REQUIRED MAXIMAL VASOPRESSOR THERAPY AND WAS UNABLE TO MAINTAIN ADEQUATE BLOOD PRESSURE. GIVEN THE SEVERITY OF HIS CONDITION AND LACK OF CLINICAL IMPROVEMENT, THE FAMILY REQUESTED TRANSITION TO COMFORT-FOCUSED CARE. LIFE-SUSTAINING THERAPIES WERE WITHDRAWN, AND THE PATIENT EXPIRED. THE REPORTED HYPOTENSION IS CONSISTENT WITH PROFOUND CARDIOGENIC SHOCK AND PROGRESSIVE HEMODYNAMIC COLLAPSE RELATED TO THE UNDERLYING AMI/CGS. THE DEVICE WILL BE CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, GIVEN THE PATIENT¿S PRESENTATION WITH ADVANCED CARDIOGENIC SHOCK (SCAI SHOCK STAGE E), DEPENDENCE ON MAXIMAL PRESSOR SUPPORT, AND SUBSEQUENT WITHDRAWAL OF CARE, THE DEATH IS MOST LIKELY ATTRIBUTED TO THE SEVERITY OF THE UNDERLYING CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842051 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027862312 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| D