BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 24399685 · Received February 20, 2026

    Report

    Report Number
    3002808486-2026-00031
    Event Type
    Injury
    Date Received
    February 20, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 28, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002449183
    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: IN 2022: EMERGENCY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WAS PERFORMED FOR IMPENDING RUPTURE OF A THORACIC AORTIC ANEURYSM. USING A 2-DEBRANCH TECHNIQUE, ZTA-P-42-225-W1 (PROXIMAL SIDE, CN-(B)(4)) AND ZTA-DE-34-112-W1 (DISTAL SIDE, THIS COMPLAINT) WERE PLACED FROM ZONE 1. DATE UNKNOWN: FINDINGS SUGGESTIVE OF A PROXIMAL TYPE I ENDOLEAK DUE TO PROXIMAL ANEURYSM EXPANSION WERE OBSERVED ON THE PROXIMAL SIDE OF THE ZTA-P-42-225-W1 PLACED IN ZONE 1. COIL EMBOLIZATION WAS PERFORMED FOR THE ENDOLEAK. (B)(6) 2026: ADDITIONAL PROCEDURE WAS PERFORMED FOR A DISTAL TYPE I ENDOLEAK DUE TO ANEURYSM EXPANSION AT THE DISTAL END OF THE PREVIOUSLY PLACED ZTA-DE-34-112-W1. ZTA-P-28-109-W1 AND ZTA-P-36-209-W1 WERE PLACED OVERLAPPING THE EXISTING STENT GRAFT, STARTING JUST ABOVE THE CELIAC ARTERY. THE PROCEDURE WAS COMPLETED WITHOUT ENDOLEAK. PROXIMAL TYPE I ENDOLEAK DUE TO PROXIMAL ANEURYSM EXPANSION HAS BEEN ALSO IDENTIFIED. HOWEVER, IT WAS DETERMINED TO BE CONTROLLED BY THE PREVIOUS COIL EMBOLIZATION, AND TREATMENT DURING THIS TEVAR WAS NOT PLANNED. ADDITIONALLY, DURING THE ANGIOGRAPHY PERFORMED FROM THE PROXIMAL SIDE DURING THIS TEVAR, THE PHYSICIAN JUDGED THAT THE FILLING OBSERVED WITHIN THE ANEURYSM COULD POTENTIALLY BE DUE TO TYPE II ENDOLEAK RATHER THAN PROXIMAL TYPE I ENDOLEAK, SO IT WAS DECIDED TO MONITOR THE SITUATION AND DETERMINE THE TREATMENT PLAN FOR THE PROXIMAL NECK EXPANSION LATER. (B)(6) 2026: THE REP RECEIVED A NOTIFICATION OF THE PATIENT'S DEATH FROM THE DISTRIBUTOR. HE WAS TOLD THAT THE PATIENT'S CONDITION DETERIORATED RAPIDLY AFTER RETURNING TO THE WARD AND DIED SEVERAL HOURS AFTER THE TEVAR ENDED DUE TO RUPTURE OF THE PROXIMAL NECK ANEURYSM. PATIENT OUTCOME: THE PATIENT SUDDENLY DETERIORATED AFTER RETURNING TO THE WARD AND DIED FROM THE RUPTURE OF ANEURYSM IN THE PROXIMAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541654 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G44918 E4314734 00827002449183

    Patients

    Seq Age Sex Outcome Treatment
    1