BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA

    MDR report key: 25135655 · Received May 11, 2026

    Report

    Report Number
    1220648-2026-07718
    Event Type
    Death
    Date Received
    May 11, 2026
    Date of Event
    May 6, 2026
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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). 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.

    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.

    Description of Event or Problem · 0

    CLINICAL NARRATIVE: AN IMPELLA 5.5 DEVICE WAS INSERTED SURGICALLY INTO THE RIGHT AXILLARY/SUBCLAVIAN ARTERY IN A 75-YEAR-OLD MALE PATIENT WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), PRESENTING IN SCAI STAGE C SHOCK, ON MULTIPLE INOTROPES AND VASOPRESSORS PRIOR TO INITIATION OF SUPPORT. THE IMPELLA WAS INSERTED FOR VENTRICULAR SUPPORT DURING A CARDIOTHORACIC (CT) SURGERY (CORONARY ARTERY BYPASS AND MAZE PROCEDURE.) WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU), NOTED TO HAVE LEFT SIDED PARALYSIS AND CT HEAD/NECK CONFIRMED LARGE RIGHT MIDDLE CEREBRAL ARTERY EMBOLIC INFARCT. PHYSICIAN NOTES THAT PATIENT HAD SIGNIFICANT CALCIFICATIONS ON ASCENDING AORTA AND THAT CROSS CLAMPING AORTA DURING SURGERY MAY HAVE CONTRIBUTED TO DISLODGING CALCIFICATION. AFTER 1 DAY ON SUPPORT, PATIENT MADE DO NOT RESUSCITATE AND EXPIRED ON SUPPORT. THE IMPELLA FUNCTIONED AT P-8 AT 4.5 L/MIN AS INTENDED. 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 TO RIGHT MIDDLE CEREBRAL EMBOLIC STROKE LIKELY CAUSED BY DISLODGING CALCIFICATION ON AORTA DURING CROSS CLAMP PERFORMED DURING CORONARY ARTERY BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279851 IMPELLA TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026814070 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1