BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 25298592 · Received May 27, 2026

    Report

    Report Number
    1820334-2026-00549
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 27, 2026
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    00827002552364
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATED BY MFG?: THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 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

    IT WAS REPORTED THAT A TYPE 3B ENDOLEAK WAS IDENTIFIED ON A ZENITH FLEX SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG DURING A FOLLOW UP SCAN FOR AN UNKNOWN PATIENT. THE INDEX ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE WAS COMPLETED ON (B)(6) 2025, IN WHICH THE FOLLOWING DEVICES WERE IMPLANTED: WILLIAM COOK AUSTRALIA: ZENITH ILIAC BRANCH, ZBIS-12-45-41-US WILLIAM COOK AUSTRALIA: ZENITH ILIAC BRANCH, ZBIS-12-61-41-US COOK INCORPORATED: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, TFFB-28-82-ZT COOK INCORPORATED: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-13-56-ZT. COOK INCORPORATED: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-13-74-ZT. COOK INCORPORATED: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-16-39-ZT. COOK INCORPORATED: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-16-39-ZT. COOK INCORPORATED: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-16-74-ZT. COOK INCORPORATED: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG, ZSLE-16-90-ZT. THERE WAS NO DIFFICULTY EXPERIENCED DURING DEVICE DEPLOYMENT, AND THE PATIENT DID NOT HAVE CALCIFIED OR TORTUOUS ANATOMY. HIGH PRESSURE OR OBSTRUCTION WITHIN THE GRAFTS WERE DENIED BY THE USER. ON A FOLLOW UP SCAN COMPLETED ON (B)(6) 2026, TYPE 3B ENDOLEAKS WERE FOUND TO BE ORIGINATING FROM THE FOUR 16MM ZSLE ILIAC LEG GRAFTS. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE FOR ALL IMPLANTED ZSLE GRAFTS TO BE RELINED. THE PATIENT WILL CONTINUE TO BE MONITORED. THIS REPORT CAPTURES A TYPE 3B ENDOLEAK FROM ONE OF THE ZENITH FLEX SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG GRAFTS (ZSLE-16-39-ZT), IN WHICH THE PATIENT REQUIRED AN ADDITIONAL PROCEDURE FOR THE GRAFT TO BE RELINED. ADDITIONAL TYPE 3B ENDOLEAKS FROM OTHER 16MM ZSLE LEG GRAFTS ARE REFERENCED IN REPORTS WITH PATIENT IDENTIFIER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114485 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55236 16361020 00827002552364

    Patients

    Seq Age Sex Outcome Treatment
    1