BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION

    MDR report key: 24565853 · Received March 11, 2026

    Report

    Report Number
    9680654-2026-00047
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 10, 2026
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MIH
    UDI-DI
    10827002386164
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MORE THAN 4 YEARS POST IMPLANT PROCEDURE, THE PATIENT PRESENTED WITH BUTTOCK AND LEG PAIN. A CTA ON (B)(6) 2026 SHOWS THE RIGHT IBD IS OCCLUDED, AND THE OCCLUSION EXTENDS TO RIGHT POPITEAL. THE PHYSICIAN NOTED THAT THE LEFT INTERNAL ILIAC WAS ALSO OCCLUDED. PHYSICIAN STATED THAT IT LOOKS CHRONIC AND LIKELY OCCLUDED SOME TIME AGO. ON FURTHER IMAGING REVIEW THE PHYSICIAN NOTED THAT THE OCCLUSION EXTENDS THROUGH THE RIGHT-SIDE BRIDGING LIMB AND UP INTO THE MAIN BODY. DR PLANS TO ATTEMPT AN EMBOLECTOMY TO RE-ESTABLISH FLOW DOWN RIGHT LEG. NO SECONDARY INTERVENTION PLANNED FOR LEFT INTERNAL ILIAC. DR WILL GET HAEMOTOLOGY DEPARTMENT TO REVIEW PATIENT FOR POTENTIAL CLOTTING DISORDER. RELATED COMPLAINTS: (B)(4): ZBIS-12-45-41 LOT NUMBER: A1122600 CTA SCAN REVIEW BY PHYSICIAN ON (B)(6) 2026 SHOWED THAT THE RIGHT IBD WAS OCCLUDED, AND THE OCCLUSION EXTENDS TO RIGHT POPITEAL. (B)(4): ZBIS-12-45-41 LOT NUMBER: A112257 LEFT INTERNAL ILIAC NOTED TO BE OCCLUDED DURING IMAGING REVIEW BY PHYSICIAN ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601687 ZENITH BRANCH ENDOVASCULAR GRAFT ILIAC BIFURCATION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM A. COOK AUSTRALIA, PTY LTD G38616 A1122600 10827002386164

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention