BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT

    MDR report key: 24674303 · Received March 24, 2026

    Report

    Report Number
    3002808486-2026-00047
    Event Type
    Injury
    Date Received
    March 24, 2026
    Report Date
    March 24, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ALPHA GRAFT HAS FRACTURED, DO NOT KNOW WHEN IMPLANT DATE WAS. IDENTIFIED IN THE LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736942 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown