BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    MDR report key: 24158964 · Received January 23, 2026

    Report

    Report Number
    3002808486-2026-00010
    Event Type
    Injury
    Date Received
    January 23, 2026
    Date of Event
    January 5, 2026
    Report Date
    May 21, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002448704
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): 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: (B)(6) 2022: 81-YEAR-OLD MALE PATIENT UNDERWENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). TEVAR WAS PERFORMED ON A DESCENDING THORACIC ANEURYSM (NEAR TH6-TH9) USING ZTA-P-34-113-W1 (E4197187) AND ZTA-DE-34-112-W1 (E4259250). IN THIS CASE, THE PROCEDURE WAS EXTENDED WITH A 112MM EXTENSION, WITH THE UNDERSTANDING THAT 113MM WAS INSUFFICIENT, IN ORDER TO SHORTEN THE TREATMENT LENGTH. (B)(6) 2026: AFTER PLACING ZTA-PT-42-38-173-W1 (E4479878, THIS COMPLAINT) IN ENDOLEAK TREATMENT, A 5F 110CM PIGTAIL CATHETER WAS USED VIA THE ZTA DELIVERY SYSTEM FOR ANGIOGRAPHY. DUE TO THE LENGTH OF THE PIGTAIL, IT WAS UNABLE TO REACH THE CENTER OF THE ZTA-PT-42-38-173-W1. WHEN ATTEMPTING TO ADVANCE THE SHEATH SLIGHTLY, IT CAUGHT ON THE DISTAL STRUCTURE OF THE ZTA-PT-42-38-173-W1. FLUOROSCOPY REVEALED THAT THE STRUCTURE OF THE DISTAL STENT WAS TILTED. A ZTA-DE-38-94-W1 (E4782543) WAS ADDED TO CORRECT THE STRUCTURE. AN ANGIOGRAM CONFIRMED NO DELAYED BLOOD FLOW AND THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: A ZTA-DE-38-94-W1 (E4782543) WAS ADDED TO CORRECT THE STRUCTURE. THE PATIENT WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420365 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44870 E4479878 00827002448704

    Patients

    Seq Age Sex Outcome Treatment
    1