BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT

    MDR report key: 24923004 · Received April 20, 2026

    Report

    Report Number
    3002808486-2026-00067
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 19, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). G4 - PMA/510(K) #) SIMILAR TO DEVICE MARKETED UNDER: 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 STUDY, WCE-MDR2091: EU CUSTOM MADE AORTIC DATA COLLECTION PROJECT: ON THE (B)(6) 2026 (5 DAYS POST-PROCEDURE) THE PATIENT HAD A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SCAN WITH CONTRAST PERFORMED. THIS REVEALED A PERSISTENT TYPE IV ENDOLEAK. ON THE PROCEDURAL IMAGING, (B)(6) 2026 A TYPE IV ENDOLEAK HAD ALREADY BEEN INDICATED. ALL THE STENT GRAFTS WERE PATENT. NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUE(S). ALL INTENDED SIDE BRANCH STENTS WERE INTACT. PATIENT OUTCOME: THE SITE NOTED THE ENDOLEAK WAS NOT TREATED AT THIS TIME. THE PATIENT WILL BE FOLLOWED IN THE STUDY PROGRAM FOLLOW UP VISITS. NO OTHER OUTCOME INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167224 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1