BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 23974214 · Received January 6, 2026

    Report

    Report Number
    3002808486-2026-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 26, 2025
    Report Date
    May 21, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002346963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: P140016. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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: AFTER THAT THE GRAFT ARRIVED IN THE THORACIC AORTA WITH THE PROXIMAL MARKER JUST BELOW THE LEFT CAROTID ARTERY, DURING THE FIRST CM PULL BACK DOTT. THE PHYSICIAN NOTED THAT THE BLACK WHEEL ON THE GREEN ROTATION HANDLE WAS NOT IN SITU AND THE BLACK HANDPIECE WAS DISCONNECTED SO IT WAS DECIDED TO PULL OUT THE DELIVERY SYSTEM AND USE ANOTHER ZTA AND TRIED ON THE WORKBENCH TO UNSHEATH THE GRAFT. THE PULL BACK WAS REALLY HARD AND THE BLACK HAND PIECE MOVING DURING THIS MOVEMENT. PATIENT OUTCOME: ANOTHER ZTA WAS USED TO TREAT THE THORACIC AORTA RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32640 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G34696 E4747539 00827002346963

    Patients

    Seq Age Sex Outcome Treatment
    1