BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 23955821 · Received January 5, 2026

    Report

    Report Number
    3002808486-2026-00003
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 23, 2025
    Report Date
    May 11, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002449435
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: APPROACH: RIGHT FEMORAL ARTERY (FA) ANATOMY: VASCULAR GRAFT WITH STENOSIS AND TORTUOSITY THE CASE WAS AN EMERGENCY PROCEDURE. DURING DELIVERY, RESISTANCE WAS ENCOUNTERED WITHIN THE GRAFT. DESPITE MULTIPLE ATTEMPTS, THE DEVICE COULD NOT CROSS THE GRAFT. UPON WITHDRAWAL, INSPECTION REVEALED A POSITIONAL GAP BETWEEN THE SHEATH TIP AND THE DILATOR, AND THE SHEATH TIP WAS BULGING. CONSIDERING SAFE USE, A BACKUP DEVICE OF THE SAME SPECIFICATION WAS UTILIZED, WHICH WAS SUCCESSFULLY DELIVERED AND DEPLOYED WITHOUT ANY ISSUES. PATIENT OUTCOME: NO HEALTH HAZARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618847 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44943 E4369809 00827002449435

    Patients

    Seq Age Sex Outcome Treatment
    1