BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 25161655 · Received May 13, 2026

    Report

    Report Number
    3002808486-2026-00086
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    March 14, 2026
    Report Date
    May 13, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002347199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    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 STUDY: (WCE-1713: ZENITH ALPHA THORACIC POST MARKET RETROSPECTIVE STUDY): TYPE 1B ENDOLEAK WAS ON THE ZTA-P-46-125 PLACED DURING THE SECONDARY INTERVENTION. ON (B)(6) 2026, FOLLOW-UP COMPUTED TOMOGRAPHY (CT) REVEALED PATENT STUDY DEVICES, THROMBUS IN A STUDY DEVICE, NO DEVICE ISSUES, AND A TYPE IB ENDOLEAK. ON THE SAME DATE, THE PATIENT WAS DIAGNOSED WITH AORTIC RUPTURE AT THE STENTED SEGMENT (B)(4), MFR REPORT # 3002808486-2026-00076). THIS WAS TREATED WITH A SECONDARY INTERVENTION ON THE SAME DATE, WHICH WAS DISTAL PLACEMENT OF A PROXIMAL COMPONENT (ZTA-P-46-125). THIS WAS CONSIDERED UNSUCCESSFUL AS THE TYPE IB ENDOLEAK PERSISTED. ON (B)(6) 2026, ANOTHER SECONDARY INTERVENTION WAS DONE--PLACEMENT OF A T-BRANCH DEVICE. PATIENT OUTCOME: THE 2ND SECONDARY INTERVENTION WAS CONSIDERED SUCCESSFUL. THE EVENT WAS CONSIDERED RESOLVED WITHOUT SEQUELAE ON 30MAR2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483096 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G34719 E4807967 00827002347199

    Patients

    Seq Age Sex Outcome Treatment
    1