BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT

    MDR report key: 25157985 · Received May 13, 2026

    Report

    Report Number
    3002808486-2026-00084
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    June 12, 2021
    Report Date
    May 13, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002242654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: P180001. 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-1616: ZENITH TX2 DISSECTION W/PRO-FORM AND Z-TRAK PLUS (ZDEG)): REPORTED TYPE 1B ENDOLEAK 761 DAYS POST PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN AORTIC DISSECTION VIA PERCUTANEOUS LEFT FEMORAL ARTERY UNDER GENERAL ANESTHESIA. THE PROXIMAL ZONE OF GRAFT IMPLANTATION WAS ZONE 4. THE SITE INDICATED THE DISTAL LOCATION OF DISSECTION AS UNKNOWN. THE PROCEDURE ANGIOGRAPHY REPORTED THAT THE STUDY DEVICE WAS PATENT. THERE WAS NO SEPARATION OR EVIDENCE OF DEVICE INTEGRITY ISSUES. ON (B)(6) 2019, SIX DAYS POST PROCEDURE, THE POST PROCEDURE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) WITH CONTRAST WAS COMPLETED. THE CT SHOWED THE INNOMINATE/BRACHIOCEPHALIC, LEFT COMMON CAROTID (LCC), CELIAC, SUPERIOR MESENTERIC (SMA), RIGHT RENAL, LEFT RENAL, LEFT COMMON ILIAC, RIGHT INTERNAL ILIAC, LEFT INTERNAL ILIAC AND THE STUDY DEVICE WERE PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES AND NO ENDOLEAKS. THE 30-DAY, SIX-MONTH AND 12-MONTH FOLLOW-UP CT WITHOUT CONTRAST WAS NOT COMPLETED. ON (B)(6) 2021, 620 DAYS POST PROCEDURE, THE TWO-YEAR FOLLOW-UP CLINICAL ASSESSMENT WAS COMPLETED. THE CT SHOWED LEFT SUBCLAVIAN (LSA) WAS OCCLUDED. THE CELIAC, SMA, RIGHT RENAL, LEFT RENAL, AND THE STUDY DEVICE WERE PATENT. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED, AND THE ABDOMINAL FALSE LUMEN FLOW WAS PARTIALLY THROMBOSED WITH AN UNKNOWN SOURCE. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 761 DAYS POST PROCEDURE, THE PATIENT HAD AN UNSCHEDULED CT IMAGING WITH CONTRAST WAS COMPLETED. THE CELIAC, SMA, RIGHT RENAL, LEFT RENAL, RIGHT COMMON ILIAC, LEFT COMMON ILIAC AND THE STUDY DEVICE WERE PATENT. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. THE ABDOMINAL FALSE LUMEN FLOW WAS PATENT WITH A PRIMARY TEAR TYPE IB-DISTAL ENDOLEAK. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 976 DAYS POST PROCEDURE, THE THREE-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CELIAC, SMA, RIGHT RENAL, LEFT RENAL, AND THE STUDY DEVICE WERE PATENT. THE LSA WAS OCCLUDED. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED, AND THE ABDOMINAL FALSE LUMEN FLOW WAS PARTIALLY THROMBOSED WITH AN UNKNOWN SOURCE. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 1150 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A HEMORRHAGIC STROKE IN BOTH HEMISPHERES. THE PATIENT WAS TREATED WITH NON-VASCULAR SURGICAL TREATMENT. THE SITE CONSIDERED THIS EVENT NOT RELATED TO THE STUDY DEVICE. THE SITE CONSIDERED THIS EVENT NOT RELATED TO THE STUDY PROCEDURE. THERE WAS NO PRE-EXISTING OR OTHER CONDITION THAT CONTRIBUTED TO THIS EVENT. THE PATIENT DIED ON (B)(6) 2022, WITH CAUSE OF DEATH BEING ¿DEEP LEFT SYLVIAN ISCHEMIC STROKE¿. DEATH WAS DETERMINED BY IN-HOSPITAL EVALUATION AT DEMISE. NO AUTOPSY WAS PERFORMED OR DEATH REPORTED PROVIDED. THE SITE COMMENTED ¿PROGRESSION OF HIS STROKE WITH NO POSSIBILITY OF RECOVERY¿. PATIENT OUTCOME: THE PATIENT DIED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302497 ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G24265 E3799564 00827002242654

    Patients

    Seq Age Sex Outcome Treatment
    1