BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25179513 · Received May 14, 2026

    Report

    Report Number
    1220648-2026-07859
    Event Type
    Death
    Date Received
    May 14, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT-DEVICE INTERACTION (MAJOR BLEED): THE ROOT CAUSE OF THE INJURY WAS NOT DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS.

    Additional Manufacturer Narrative · 0

    THE DATE OF DEATH IS CURRENTLY UNKNOWN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. 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 B2 (DATE OF DEATH), D3 (MANUFACTURER FAX). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. ADDITIONAL INFORMATION WAS PROVIDED IN B5 (EVENT DESCRIPTION). UPON REVIEW, IT WAS ADDED DUE TO NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN PROVIDED IN D6B.

    Description of Event or Problem · 0

    AN IMPELLA 5.5 DEVICE WAS INSERTED INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 70-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) AND DIALYSIS, PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI STAGE E SHOCK, AND ON A VENTILATOR FOR RESPIRATORY SUPPORT, PRIOR TO INITIATION OF SUPPORT. WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT HAD A GASTROINTESTINAL (GI) BLEED WITH A BLACK, TARRY BOWEL MOVEMENT. IT IS UNKNOWN IF THE PATIENT HAD ANY PREVIOUS GI BLEEDS PRIOR TO TRANSFER FROM THE OSH. IT WAS REPORTED THAT THE PATIENT EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-8 AT 4.5L/MIN AS INTENDED. BLEEDING IS A KNOWN RISK DUE TO THE IMPELLA'S ANTICOAGULATION AND PURGE REQUIREMENTS. THE IMPELLA IS BEING CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, IS UNLIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL CONDITION OF A CRITICALLY ILL PATIENT WITH ACUTE MYOCARDIAL INFARCTION AND CARDIOGENIC SHOCK, COMPLICATED BY STAGE E SHOCK.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION STATES THAT DATE/TIME OF EXPLANT IS CURRENT, AND SURVIVAL OUTCOME AT EXPLANT WAS REVIEWED AS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291607 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026741741 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1