BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25183222 · Received May 15, 2026

    Report

    Report Number
    1220648-2026-07880
    Event Type
    Death
    Date Received
    May 15, 2026
    Date of Event
    May 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    H6: UPDATED CODES BASED ON THE RESULTS OF THE INVESTIGATION. H11: UPDATED BASED ON THE RESULTS OF THE INVESTIGATION AND ADDED CLINICAL REVIEW. CORRECTED INFORMATION HAS BEEN PROVIDED IN D3 (MANUFACTURER FAX); D10 (CONCOMITANT MED PRODUCTS). UPON REVIEW, IT WAS IDENTIFIED THAT THE INFORMATION WAS INADVERTENTLY NOT SUBMITTED IN THE INITIAL REPORT. 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 INTO THE RIGHT FEMORAL ARTERY IN A 41-YEAR-OLD MALE PATIENT PRESENTING IN ACUTE MYOCARDIAL INFARCTION (AMI) AND CARDIOGENIC SHOCK (CGS), IN SCAI E SHOCK, AND ON MULTIPLE INOTROPES AND VASOPRESSORS, PRIOR TO INITIATION OF SUPPORT. ADDITIONALLY, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT WAS INITIATED WHILE ON SUPPORT. WHILE IN THE CATH LAB, THE IMPELLA WAS INSERTED AND THE PHYSICIAN NOTICED A DISSECTION OF THE ASCENDING AORTA. IT WAS REPORTED THAT THE TEAM THOUGHT THE DISSECTION WAS PRESENT PREVIOUS TO THE IMPELLA INSERTION; HOWEVER, THERE WAS NO PRIOR IMAGING TO CONFIRM. NO SURGERY WAS PERFORMED AS THE PATIENT WAS NOT A SURGICAL CANDIDATE. WHILE ON SUPPORT, THE DEVICE FUNCTIONED AS INTENDED FOR LV UNLOADING AT P-9 AT 3.8L/MIN WITH D5W HEPARIN IN THE PURGE SOLUTION. AFTER 10 HOURS ON SUPPORT, THE FAMILY WITHDREW CARE AND THE PATIENT EXPIRED. THE IMPELLA IS BEING CONSERVATIVELY REPORTED FOR DEATH; HOWEVER, IS NOT LIKELY TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, WHICH WAS MOST LIKELY DUE TO THE CLINICAL PRESENTATION OF A CRITICALLY ILL PATIENT IN CARDIOGENIC SHOCK, COMPLICATED BY STAGE E SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422763 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2027825328 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1