BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 24505410 · Received March 4, 2026

    Report

    Report Number
    1220648-2026-04446
    Event Type
    Death
    Date Received
    March 4, 2026
    Date of Event
    February 17, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A4 IS UNKNOWN. 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

    CORRECTED INFORMATION WAS PROVIDED IN D1 (BRAND NAME). UPON REVIEW, IT WAS IDENTIFIED THAT THE SECTION D BRAND NAME HAS NOW BEEN UPDATED. CORRECTED INFORMATION WAS PROVIDED IN D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. CORRECTED INFORMATION WAS PROVIDED IN D4 (CATALOG). UPON REVIEW, THE SECTION D CATALOG NUMBER HAS NOW BEEN UPDATED. H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Description of Event or Problem · 0

    AN IMPELLA CP WAS INSERTED VIA THE FEMORAL ARTERY TO SUPPORT THE 77 YEAR OLD FEMALE PATIENT WHO HAD BEEN ADMITTED INTO MEDICAL CENTER WITH INDICATION OF ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, PRESENTING IN SCAI STAGE E SHOCK. PRIOR TO THE PUMP SUPPORT PLACEMENT THE PATIENT WAS ON INOTROPES, VASOPRESSORS, AND A VENT FOR RESPIRATORY NEEDS. THE UNDERLYING HISTORY WAS NOT SHARED. ON THE DAY OF IMPLANT THE MEDICAL TEAM WAS ROUNDING IN THE ICU AND FOUND THE ACCESS SITE TO BE BLEEDING. THE TEAM RE-DRESSED THE CP SITE AND INFUSED BOTH RED BLOOD AND PLATELETS TO THE PATIENT. THEY DID NOT THE ACCESS/LIMB ALSO HAD THE SWAN AND REPERFUSION SHEATH, AS THE FEMORAL SITE WAS NOT USED ONLY FOR THE IMPELLA CP PUMP. THE PUMP RAN AND SUPPORTED FOR A TOTAL OF 9 DAYS TIL THE TEAM AND FAMILY MADE DECISION TO WITHDRAW CARE. ANTICOAGULATION NECESSARY FOR THE PUMP PLACEMENT AND SUPPORT CAN CONTRIBUTE TO ACCESS SITE BLEEDING. 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 E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140780 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027834011 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1