ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2025-00214
- Event Type
- Death
- Date Received
- September 26, 2025
- Date of Event
- October 20, 2019
- Report Date
- May 11, 2026
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FROM A POST-MARKET STUDY COOK BECAME AWARE OF THIS EVENT. ON (B)(6) 2019, AN 81-YEAR-OLD MALE PATIENT UNDERWENT A TEVAR (THORACIC ENDOVASCULAR AORTIC REPAIR) PROCEDURE FOR TBAD WITH PLACEMENT OF A ZDEG-P-38-154-PF (COMPLAINT DEVICE). PROCEDURAL ANGIOGRAPHY REPORTED THAT THE THORACIC AND ABDOMINAL FALSE LUMENS WERE PATENT. ON (B)(6) 2019, FOUR DAYS POST PROCEDURE, A FOLLOW-UP CT WITH CONTRAST SHOWED THAT ALL VESSELS AND THE DEVICE WERE PATENT. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED, AND THE ABDOMINAL FALSE LUMEN WAS PATENT DUE TO A TYPE IB ENDOLEAK FROM THE PRIMARY TEAR. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2020, 264 DAYS POST PROCEDURE, THE FOLLOW-UP CT WITH CONTRAST SHOWED THAT THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PATENT. TYPE 1B ENDOLEAK FROM THE PRIMARY TEAR WAS REPORTED AS SOURCE OF FALSE LUMEN FLOW. ON (B)(6) 2021, 474 DAYS POST PROCEDURE, THE FOLLOW-UP CT CONTINUED TO REPORT A TYPE 1B ENDOLEAK. INFORMATION ABOUT FALSE LUMEN PATENCY WAS NOT COMPLETED. ON (B)(6) 2021, 635 DAYS POST PROCEDURE, THE FOLLOW UP CT SHOWED AN ANTEGRADE PROGRESSION OF DISSECTION. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED, AND THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED. THE PROGRESSION OF DISSECTION WAS NOT TREATED. THE THREE-, FOUR- AND FIVE-YEAR FOLLOW-UPS HAVE NOT BEEN COMPLETED. ON (B)(6) 2025, 1965 DAYS POST PROCEDURE, THE PATIENT EXPERIENCED A THORACIC AORTIC RUPTURE LEADING TO DEATH. THE SITE NOTED ¿INCREASE IN ULCERATION AT THE END OF THE STENT SINCE 2021¿. PER THE SITE RELATED TO THE AORTIC RUPTURE ¿THORACIC AORTIC ANEURYSM WITH IMMINENT RISK OF DISSECTION AND INDICATION FOR EMERGENCY SURGERY REFUSED BY THE PATIENT.¿ WHEN ASKED IF THE REPORTED TYPE 1B ENDOLEAK WAS A ¿TRUE ENDOLEAK¿ BETWEEN STENT GRAFT AND INTIMA OR AN ENTRY FLOW FROM AN ENTRY TEAR AT THE DISTAL END OF THE STENT GRAFT THE SITE STATED THAT IT WAS: ¿NOT A TRUE TYPE 1B, IT IS RE-ENTRY FLOW FROM A DISTAL ENTRY TEAR.¿ THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR THE REPORTED ENDOLEAK. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. A DEVICE EVALUATION COULD NOT BE PERFORMED AS THE VENT IS RELATED TO THE IMPLANTED STENT GRAFT. THE COMPLAINT ORIGINATES FROM A PMCF STUDY WHERE IMAGING IS NOT COLLECTED WHY NO IMAGES WERE AVAILABLE FOR REVIEW. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES 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 INSTRUCTIONS FOR USE OR LABEL. THIS IS A KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTION FOR USE. ENDOLEAKS, SINE (STENT-INDUCED NEW ENTRY TEAR), AORTIC RUPTURE AND DEATH ARE ALL KNOWN POTENTIAL ADVERSE EVENTS COVERED BY THE IFU. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. THE REPORTED INFORMATION REGARDING THE FALSE LUMEN PATENCIES AND TYPE 1B ENDOLEAK IS INCONSISTENT MAKING IT DIFFICULT TO ASSESS THE EVENT. BASED ON THE REPORTED INFORMATION IT SEEMS THAT A MINOR ENDOLEAK, PERFUSING THE FALSE LUMEN THROUGH THE PRIMARY THORACIC TEAR, PERSISTED FROM THE FOLLOW-UP FOUR DAYS POST PROCEDURE UNTIL A POINT BETWEEN THE ONE- AND TWO-YEAR FOLLOW-UP 635 DAYS POST PROCEDURE WHERE IT WAS NO LONGER REPORTED. AT 1965 DAYS POST PROCEDURE THE PATIENT PRESENTS WITH AORTIC RUPTURE SEEMINGLY DUE TO A NEW PRIMARY TEAR THAT HAD DEVELOPED AT THE DISTAL END OF THE ZDEG-P-38-154-PF (COMPLAINT DEVICE). ALTHOUGH THIS CANNOT BE CONFIRMED WITHOUT IMAGING THIS SERIOUS COMPLICATION IS A WELL-KNOWN ADVERSE EVENT THAT CAN BE CAUSED OVER TIME BY THE DEVICE EXERTING PRESSURE ON THE VESSEL WALL. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.
MANUFACTURERS REF# (B)(4). 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.
MANUFACTURER¿S 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.
MANUFACTURER¿S 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
DESCRIPTION OF EVENT ACCORDING TO STUDY (B)(6): ZENITH TX2 DISSECTION W/PRO-FORM AND Z-TRAK PLUS (ZDEG): ON (B)(6) 2019 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN AORTIC DISSECTION VIA PERCUTANEOUS RIGHT AND LEFT FEMORAL ARTERY UNDER GENERAL ANESTHESIA. THE PROCEDURE ANGIOGRAPHY REPORTED A THORACIC AND ABDOMINAL FALSE LUMEN WAS PATENT. SITE HAS NOT PROVIDED ADDITIONAL INFORMATION. ON (B)(6) 2019, FOUR DAYS POST PROCEDURE, THE FOLLOW-UP COMPUTED TOMOGRAPHY (CT) WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED, AND THE ABDOMINAL FALSE LUMEN WAS PATENT WITH THE TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. THE 30 DAYS CLINICAL ASSESSMENT, FOLLOW-UP BLOOD WORK, AND FOLLOW-UP CT WERE NOT COMPLETED. ON (B)(6) 2020, 264 DAYS POST PROCEDURE, THE SIX-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED THE CELIAC, SUPERIOR MESENTERIC (SMA), LEFT RENAL, RIGHT COMMON ILIAC, AND LEFT COMMON ILIAC WERE PATENT, INCLUDING THE STUDY DEVICE. THE INNOMINATE, LEFT COMMON CAROTID (LCC), LEFT SUBCLAVIAN (LSA), RIGHT RENAL, AND RIGHT AND LEFT INTERNAL ILIACS HAD UNKNOWN PATENCY. TYPE IB ENDOLEAK FROM THE FALSE LUMEN OF THORACIC AND ABDOMINAL. THE FALSE LUMEN FLOW FROM THE PRIMARY TEAR OF THE THORACIC IS REPORTED AS PARTIALLY THROMBOSED AND THE ABDOMINAL FALSE LUMEN AS PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 474 DAYS POST PROCEDURE, THE 12-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED THE CELIAC, SMA, RIGHT AND LEFT RENAL, AND RIGHT COMMON ILIAC WERE PATENT, INCLUDING THE STUDY DEVICE. THE INNOMINATE, LCC, LEFT COMMON ILIAC, AND RIGHT AND LEFT INTERNAL ILIACS HAD UNKNOWN PATENCY. THE SITE HAS NOT COMPLETED DATA FOR THE THORACIC AND ABDOMINAL FALSE LUMENS. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES BUT ENDOLEAK TYPE IB IS NOTED. ON (B)(6) 2021, 635 DAYS POST PROCEDURE, THE TWO-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED AN ANTEGRADE PROGRESSION OF DISSECTION IN WHICH NO TREATMENT WAS DONE. THE CT SHOWED THE CELIAC, SMA, LEFT RENAL WERE PATENT, INCLUDING THE STUDY DEVICE. THE INNOMINATE, LCC, RIGHT RENAL, RIGHT AND LEFT COMMON ILIAC, AND RIGHT AND LEFT INTERNAL ILIACS HAD UNKNOWN PATENCY. THE THORACIC FALSE LUMEN WAS COMPLETELY THROMBOSED. THE SITE HAS NOT COMPLETED DATA FOR THE ABDOMINAL FALSE LUMEN FLOW. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. THE THREE-, FOUR- AND FIVE-YEAR CLINICAL ASSESSMENTS HAD NOT BEEN COMPLETED. ON (B)(6) 2025, 1965 DAYS POST PROCEDURE THE PATIENT EXPERIENCED A THORACIC AORTIC RUPTURE LEADING TO DEATH. THE SITE NOTED ¿INCREASE IN ULCERATION AT THE END OF THE STENT SINCE 2021¿. PER THE SITE RELATED TO THE AORTIC RUPTURE ¿THORACIC AORTIC ANEURYSM WITH IMMINENT RISK OF DISSECTION AND INDICATION FOR EMERGENCY SURGERY REFUSED BY THE PATIENT.¿ PATIENT OUTCOME: THE TYPE 1B ENDOLEAK WAS SEEN ON FOUR DAYS POST OP FOLLOW UP CT. SUBSEQUENT IMAGING DATA ARE INCOMPLETE. ON (B)(6) 2025, PATIENT WAS FOUND DECEASED. THE CAUSE OF DEATH "TYPE B AORTIC DISSECTION OF THE ENTIRE DESCENDING AORTA WITH LEFT HEMOTHORAX ON AORTIC RUPTURE". THE SITED NOTED THE DEATH WAS RELATED TO PRIMARY DISEASE PROGRESSION.
THE FOLLOWING WAS REQUESTED AND ANSWERED (B)(6) 2025: CAN YOU PLEASE CONFIRM THAT THE REPORTED DISTAL ENTRY TEAR IS THE PRE-EXISTING ENTRY TEAR OR A SINE (STENT GRAFT¿INDUCED NEW ENTRY)? IT¿S AN ERROR THE ABDOMINAL STATUS IS PATENT.
ADDITIONAL INFORMATION RECEIVED 02OCT2025; THE PATIENT DID NOT RECEIVE ANY TREATMENT FOR THE ENDOLEAK TYPE 1B.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490986 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G24286 | E3885365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Death |