BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 23377029 · Received October 24, 2025

    Report

    Report Number
    3002808486-2025-00231
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 20, 2025
    Report Date
    May 20, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002449688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). E1) PHONE NUMBER: (B)(6). 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: APPROACH WAS VIA THE RIGHT ACCESS ROUTE. PATIENT ANATOMY: A Y-GRAFT REPLACEMENT HAD BEEN PERFORMED. THIS WAS A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) CASE PLANNED TO ADD THE ZTA-P-42-121-W1 TO A PREVIOUSLY TREATED ANATOMY WITH NAJUTA AND VALIANT STENT GRAFTS. ADVANCEMENT OF THE INTRODUCER SHEATH WAS UNSUCCESSFUL. IT COULD NOT PASS THE TORTUOUS SEGMENT OF THE DESCENDING THORACIC AORTA. A PULL-THROUGH TECHNIQUE WAS ATTEMPTED, BUT ADVANCEMENT REMAINED DIFFICULT. ULTIMATELY, THE TEVAR PROCEDURE WAS ABORTED. PATIENT OUTCOME: NO PATIENT HEALTH HAZARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321709 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44968 E4740079 00827002449688

    Patients

    Seq Age Sex Outcome Treatment
    1