BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24608091 · Received March 16, 2026

    Report

    Report Number
    1220648-2026-05359
    Event Type
    Death
    Date Received
    March 16, 2026
    Date of Event
    March 5, 2026
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION HAS BEEN PROVIDED IN D1 AND D4. ASAE/HEMATOMA: THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE EXACT DATE OF DEATH IS UNKNOWN BUT HAS BEEN CAPTURED AS THE DATE OF EXPLANT. IF ACTUAL INFORMATION BECOMES KNOWN, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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

    AN 81 YEAR OLD MALE PRESENTED WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, WITH PRE SUPPORT CLINICAL STATUS CONSISTENT WITH SCAI SHOCK STAGE E. THE PATIENT WAS SUPPORTED WITH AN IMPELLA CP PLACED PERCUTANEOUSLY VIA THE RIGHT FEMORAL ARTERY ON (B)(6) 2026 AT 5:15 PM. THE PATIENT DEVELOPED A MINOR HEMATOMA AT THE ACCESS SITE. THE PATIENT¿S DEATH RESULTED FROM CARDIAC DETERIORATION ASSOCIATED WITH CARDIOGENIC SHOCK, WHILE THE MINOR HEMATOMA WAS CONSIDERED A CONTRIBUTING CLINICAL FACTOR BUT NOT CAUSATIVE. DEVICE PERFORMANCE WAS NOT IMPLICATED IN THE EVENT. THE DEATH IS CONSERVATIVELY BEING REPORTED TO THE IMPELLA CP BUT IS UNLIKELY A CONTRIBUTING FACTOR AND IS MOST LIKELY ATTRIBUTED TO PATIENTS LACK OF HEART RECOVERY, UNDERLYING CRITICAL CONDITION AS THEY PRESENTED IN SCAI STAGE D SHOCK ON MULTIPLE INOTROPES AND PRESSORS AND WAS VENTILATED FOR RESPIRATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669488 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. 2026811666 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention| D