BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 24688120 · Received March 25, 2026

    Report

    Report Number
    3002808486-2026-00054
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    September 18, 2018
    Report Date
    May 13, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): P180001. 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-1616: ZENITH TX2 DISSECTION W/PRO-FORM AND Z-TRAK PLUS (ZDEG). ON (B)(6) 2017 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN AORTIC DISSECTION VIA PERCUTANEOUS LEFT FEMORAL ARTERY UNDER GENERAL ANESTHESIA. THE PROCEDURE ANGIOGRAPHY REPORTED THE STUDY DEVICE WAS PATENT, NO SEPARATION OF DEVICES, NO DEVICE INTEGRITY ISSUES, NO ENDOLEAKS PRESENT AND NO EVIDENCE OF BRANCH VESSEL OBSTRUCTION AT THE COMPLETION OF THE PROCEDURE. ON (B)(6) 2017, FIVE DAYS POST PROCEDURE, THE FOLLOW-UP CLINICAL ASSESSMENT AND COMPUTED TOMOGRAPHY (CT) WITH CONTRAST WERE COMPLETED. THE CT SHOWED ALL VESSELS WERE NOT ASSESSED, AND THE STUDY DEVICE WAS PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION, DEVICE INTEGRITY ISSUES, AND NO ENDOLEAKS PRESENT. THE 30 DAYS CLINICAL ASSESSMENT, FOLLOW-UP BLOOD WORK, AND FOLLOW-UP CT WERE NOT COMPLETED. ON (B)(6) 2018, 125 DAYS POST PROCEDURE, THE SIX-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED THE INNOMINATE, LEFT COMMON CAROTID (LCC), LEFT SUBCLAVIAN (LSA), LEFT RENAL, RIGHT AND LEFT COMMON ILIAC, AND RIGHT AND LEFT INTERNAL ILIAC WERE NOT ASSESSED. THE CELIAC, SUPERIOR MESENTERIC (SMA), AND RIGHT RENAL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION, DEVICE INTEGRITY ISSUES, AND NO ENDOLEAKS PRESENT. ON (B)(6) 2018, 300 DAYS POST PROCEDURE, THE 12-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE CT IMAGING REVEALED A TYPE IB (DISTAL) ENDOLEAK AT THE DISSECTION GRAFT (ZDEG) (B)(6). THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2019, 531 DAYS POST PROCEDURE, THE TWO-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE CT IMAGING REVEALED A TYPE IB (DISTAL) ENDOLEAK AT THE DISSECTION GRAFT (ZDEG) (B)(6). THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2020, 1024 DAYS POST PROCEDURE, THE THREE-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION, DEVICE INTEGRITY ISSUES, AND NO ENDOLEAKS PRESENT. ON (B)(6) 2021, 1206 DAYS POST PROCEDURE, THE FOUR-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE CT IMAGING REVEALED A TYPE II ENDOLEAK (ORIGINATING FROM THE ACCESSORY VESSELS). THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION, AND DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 1615 DAYS POST PROCEDURE, THE FIVE-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE CT IMAGING REVEALED A TYPE IIIA (INADEQUATE OVERLAP OF MODULAR GRAFT DEVICES) ENDOLEAK (B)(6). THE SITE INDICATED THAT THE AORTIC ENDOPROSTHESIS IS THE PROXIMAL DEVICE INVOLVED AND THE AORTO-BI-ILIAC-ENDOPROSTHESIS IS THE DISTAL DEVICE INVOLVED. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. THE PATIENT WAS EXITED FROM THE STUDY FOLLOWING THE 5-YEAR VISIT AS THE FINAL STUDY VISIT WAS COMPLETED. PATIENT OUTCOME: PATIENT COMPLETED FOLLOW-UP VISITS AND EXITED THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45069 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G24284

    Patients

    Seq Age Sex Outcome Treatment
    1