BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT

    MDR report key: 23412747 · Received October 29, 2025

    Report

    Report Number
    3002808486-2025-00235
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    February 28, 2024
    Report Date
    March 13, 2026
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    00827002242661
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 H10) RELATED REPORT NUMBERS: (B)(4) (REF#: (B)(4)) AND (B)(4) (REF#: (B)(4)). 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#: (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FROM A POST-MARKET STUDY COOK BECAME AWARE OF THIS EVENT. ON (B)(6) 2021, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN AORTIC DISSECTION VIA PERCUTANEOUS RIGHT AND LEFT FEMORAL ARTERY UNDER GENERAL ANESTHESIA, WHERE A ZDEG-PT-38-204-PF WAS IMPLANTED. THE CT (COMPUTED TOMOGRAPHY) SHOWED THE STUDY DEVICE WAS PATENT. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THERE WERE NO SEPARATION OR DEVICE INTEGRITY ISSUES (B)(4). ON (B)(6) 2021, TWO DAYS POST-PROCEDURE, THE FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED A NEW ENTRY TEAR DEVELOPMENT OF THE INFRARENAL ABDOMINAL AORTA AND THE LEFT SUBCLAVIAN (LSA) WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEFT RENAL ARTERY AND INFRARENAL AORTA. THE SITE NOTED ¿INTIMAL TEAR 5CM DISTAL FROM THORACIC GRAFT ZDEG¿ IN WHICH NO TREATMENT WAS DONE AT THAT TIME. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 46 DAYS POST-PROCEDURE, THE ONE-MONTH FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED THE LEFT SUBCLAVIAN (LSA) WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE INFRARENAL AORTA. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 143 DAYS POST-PROCEDURE, THE SIX-MONTH FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEVEL OF THE RENAL ARTERIES. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 298 DAYS POST-PROCEDURE, THE 12-MONTH FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED A NEW ENTRY TEAR DEVELOPMENT OF THE DESCENDING AORTA, DISTAL TO LSA AND THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEVEL OF THE RIGHT RENAL. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 476 DAYS POST-PROCEDURE, UNSCHEDULED VISIT CT WAS COMPLETED. THE CT SHOWED THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEVEL OF THE RIGHT RENAL AND BOTH ILIACS. THE SITE NOTED AN ¿ULCERATION IN THE DISTAL THIRD OF THE DESCENDING THORACIC AORTA, DISTAL TO THE DISSECTION¿. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. THE ULCERATION WAS CAUSED BY THE D-SINE, WHICH WAS RELATED TO THE ZDEG (CURRENT COMPLAINT). ON (B)(6) 2022, 539 DAYS POST-PROCEDURE, THE PATIENT UNDERWENT A SUCCESSFUL ENDOVASCULAR SECONDARY INTERVENTION FOR A DISTAL GRAFT EXTENSION IN WHICH AN COOK ENDOVASCULAR GRAFT ZTA-PT-34-30-209 WAS PLACED AS AN ¿EXTENSION OF THORACIC GRAFT TO THE CELIAC ARTERY (TRUNK)¿. ON (B)(6) 2023, 609 DAYS POST-PROCEDURE, THE TWO-YEAR FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE RIGHT RENAL. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2024, 985 DAYS POST-PROCEDURE, THE THREE-YEAR FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED AN ANTEGRADE GROWTH OF DISSECTION AND DEVELOPMENT OF A NEW ENTRY TEAR AT THE DESCENDING AORTA, DISTAL TO LSA. ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH A SECONDARY TEAR ¿D-SINE (DISTAL TO THE STENT GRAFT)¿ (RELATED COMPLAINT) AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR TO THE ¿MULTIPLE¿. THE SITE NOTED ANTEGRADE AORTIC DISSECTION PROGRESSION IN WHICH AN ENDOVASCULAR GRAFT WAS PLACED AS AN ¿EXTENSION OF THE PREVIOUS THORACIC GRAFT TO COVER THE THORACIC AORTA¿. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. THE PATIENT DISEASED ON (B)(6) 2025, SITE STATED FOR THE CAUSE OF DEATH ¿UNKNOWN, SHE DIED IN HER SLEEP AT HOME.¿ NO AUTOPSY WAS PERFORMED AND THERE IS NO DEATH REPORT OR AUTOPSY REPORT AVAILABLE. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. EVENT IS RELATED TO IMPLANTED STENT GRAFT. THIS COMPLAINT ORIGINATES FROM A POST-MARKET STUDY (PMCF) WHERE IMAGES ARE NOT COLLECTED. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCE'S THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE IFU/AND OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSE IS FRAGILE DISSECTING AORTIC ANATOMY. AORTIC DAMAGE IS A KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTION FOR USE. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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)): ON (B)(6) 2021 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN AORTIC DISSECTION VIA PERCUTANEOUS RIGHT AND LEFT FEMORAL ARTERY UNDER GENERAL ANESTHESIA. THE COMPUTED TOMOGRAPHY (CT) SHOWED THE STUDY DEVICE WAS PATENT. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THERE WERE NO SEPARATION OR DEVICE INTEGRITY ISSUES ((B)(4), FDA REF # (B)(4)). ON (B)(6) 2021, TWO DAYS POST-PROCEDURE, THE FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED A NEW ENTRY TEAR DEVELOPMENT OF THE INFRARENAL ABDOMINAL AORTA AND THE LEFT SUBCLAVIAN (LSA) WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEFT RENAL ARTERY AND INFRARENAL AORTA. THE SITE NOTED ¿INTIMAL TEAR 5CM DISTAL FROM THORACIC GRAFT ZDEG¿ IN WHICH NO TREATMENT WAS DONE AT THAT TIME. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 46 DAYS POST-PROCEDURE, THE ONE-MONTH FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED THE LEFT SUBCLAVIAN (LSA) WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE INFRARENAL AORTA. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 143 DAYS POST-PROCEDURE, THE SIX-MONTH FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEVEL OF THE RENAL ARTERIES. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 298 DAYS POST-PROCEDURE, THE 12-MONTH FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED A NEW ENTRY TEAR DEVELOPMENT OF THE DESCENDING AORTA, DISTAL TO LSA AND THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEVEL OF THE RIGHT RENAL. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 476 DAYS POST-PROCEDURE, UNSCHEDULED VISIT CT WAS COMPLETED. THE CT SHOWED THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE LEVEL OF THE RIGHT RENAL AND BOTH ILIACS. THE SITE NOTED AN ¿ULCERATION IN THE DISTAL THIRD OF THE DESCENDING THORACIC AORTA, DISTAL TO THE DISSECTION¿. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 539 DAYS POST-PROCEDURE, THE PATIENT UNDERWENT A SUCCESSFUL ENDOVASCULAR SECONDARY INTERVENTION FOR A DISTAL GRAFT EXTENSION IN WHICH AN COOK ENDOVASCULAR GRAFT WAS PLACED AS AN ¿EXTENSION OF THORACIC GRAFT TO THE CELIAC ARTERY (TRUNK)¿ ON (B)(6) 2023, 609 DAYS POST-PROCEDURE, THE TWO-YEAR FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED THE LSA WAS OCCLUDED BUT ALL OTHER VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR AT THE RIGHT RENAL. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2024, 985 DAYS POST-PROCEDURE, THE THREE-YEAR FOLLOW-UP CT WAS COMPLETED. THE CT SHOWED AN ANTEGRADE GROWTH OF DISSECTION AND DEVELOPMENT OF A NEW ENTRY TEAR AT THE DESCENDING AORTA, DISTAL TO LSA (THIS COMPLAINT (B)(4)). ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH A SECONDARY TEAR ¿D-SINE (DISTAL TO THE STENT GRAFT)¿ ((B)(4), FDA REF # (B)(4)) AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE SECONDARY TEAR TO THE ¿MULTIPLE¿. THE SITE NOTED ANTEGRADE AORTIC DISSECTION PROGRESSION IN WHICH AN ENDOVASCULAR GRAFT WAS PLACED AS AN ¿EXTENSION OF THE PREVIOUS THORACIC GRAFT TO COVER THE THORACIC AORTA¿. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. PATIENT OUTCOME: SECONDARY INTERVENTION WITH PLACEMENT OF A ZTA-PT-34-30-209.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298745 ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G24266 E4112419 00827002242661

    Patients

    Seq Age Sex Outcome Treatment
    1