ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT
Report
- Report Number
- 3002808486-2025-00135
- Event Type
- Death
- Date Received
- June 18, 2025
- Date of Event
- March 3, 2025
- Report Date
- February 9, 2026
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 00827002231832
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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). AFTER INVESTIGATION THE EVENT IS CONSIDERED REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A WCE-1616 COOK MEDICAL ZENITH DISSECTION ENDOVASCULAR GRAFTS POST MARKET STUDY COOK BECAME AWARE OF THIS EVENT. A PATIENT WITH PREEXISTING CONDITION EPISTAXIS CAUTERIZATION AND WHO WAS PREVIOUSLY TREATED FOR AORTIC ANEURYSM WITH AORTIC ARCH OPEN REPAIR AND ENDOVASCULAR REPAIR OF THE DESCENDING THORACIC WITH ZTEG DEVICE ON (B)(6) 2014 AND TREATED WITH A ZDEG-PT-42-34-210-PF ON (B)(6) 2022, DECEASED ON (B)(6) 2025, 1112 DAYS POST PROCEDURE. PER THE SITE: ¿PATIENT SUFFERING FROM A LEAK FROM AN ENDOVASCULAR AORTIC PROTHESIS CAUSING HEMOTHORAX AND CARDIAC COMPRESSION ASSOCIATED WITH BILATERAL PULMONARY EDEMA (CURRENT COMPLAINT). COLLEGIAL DECISION WAS TO PROVIDE COMFORT CARE IN THE ABSENCE OF ANY REALISTIC THERAPEUTIC OPTION. THE SITE HAS RELATED THE DEATH TO PREEXISTING CONDITION PRIOR TO PROCEDURE AND PRIMARY DISEASE PROGRESSION. PATIENT´S MEDICAL HISTORY: THE PATIENT EXPERIENCED IATROGENIC AORTIC DISSECTION OCCURRING DURING THE PROCEDURE OF ZDEG IMPLANTATION (RELATED COMPLAINT). THE PATIENT WAS DISCHARGED (B)(6) 2022. THE EVENT WAS CONSIDERED NOT TO BE RELATED TO THE STUDY DEVICE BUT RELATED TO THE STUDY PROCEDURE. THE SITE NOTED THAT TORTUOSITY CAUSED OR CONTRIBUTED TO THE EVENT. THE EVENT WAS ALSO REPORTED TO BE RELATED TO SEVERAL ATTEMPTS TO INSERT THE DEVICE. ON (B)(6) 2022 (THREE DAYS POST-PROCEDURE), A CT REVEALED THAT THE STUDY DEVICE WAS PATENT WITH NO SEPARATION OF DEVICES, EVIDENCE OF MIGRATION, OR EVIDENCE OF DEVICE INTEGRITY ISSUES. AN ENDOLEAK WAS NOT PRESENT. ON (B)(6) 2022 (56 DAYS POST-PROCEDURE), A FOLLOW-UP CT REVEALED A TYPE IIIA ENDOLEAK BETWEEN THE ZTEG AND THE ZDEG-PT-42-34-210-PF (RELATED COMPLAINT). THE SITE INDICATED NO MIGRATION, DEFINED AS MOVEMENT GREATER THAN 10 MM. NO REPORTED DATA REGARDING ADDITIONAL TREATMENT WAS PROVIDED. ZTEG AND ZDEG WERE IMPLANTED WITH 1,5 STENT OVERLAP. THE DISTAL END OF THE ZDEG WAS IMPLANTED AT ZONE 5 REACHING THE LEVEL OF THE VISCERAL AORTA WITHOUT COVERING THE CELIAC, SUPERIOR MESENTERIC AND INFERIOR MESENTERIC ARTERIES. PROCEDURE ANGIOGRAPHY REVEALED A TYPE 1B ENDOLEAK RELATED TO ZDEG-PT-42-34-210-PF. ON (B)(6) 2023 (376 DAYS POST-PROCEDURE) THE PATIENT UNDERWENT A STAGED PROCEDURE OF A BRANCHED ENDOVASCULAR ABDOMINAL AORTIC REVASCULARIZATION AND BRANCHED ENDOVASCULAR ABDOMINAL AORTIC BRANCHED CMD IMPLANTATION. CMD WAS NOT IMPLANTED WITHIN THE ZDEG BUT FOLLOWED THE ZDEG WITHOUT OVERLAP. CMD GRAFT COULD NOT BE INSERTED HIGH ENOUGH, RESULTING IN FAILURE OF THE BRANCHED CMD TO SEAL. THE SAME DAY THE PATIENT EXPERIENCED A HEMORRHAGIC HEMISPHERIC STROKE. (B)(6) 2023 (379 DAYS POST PROCEDURE) 12-MONTH CT IMAGING AS COMPLETED. ALL VESSELS WERE PATENT WITH THE TYPE IIIA ENDOLEAK RELATED TO PROXIMAL DEVICE OF ZTEG DEVICE IMPLANTED 2014 AND DISTAL ZDEG STUDY DEVICE. THE STUDY DEVICE WAS PATENT WITH NO SEPARATION, MIGRATION, OR DEVICE INTEGRITY ISSUES. (B)(6) 2023 (607 DAYS POST-PROCEDURE) A FOLLOW-UP CT WAS DONE. ALL VESSELS WERE PATENT WITH THE TYPE IB DISTAL ENDOLEAK RELATED TO THE ABDOMINAL AORTIC BRANCHED CMD (RELATED COMPLAINT). THERE WAS ALSO A TYPE II ENDOLEAK NOTED. THE STUDY DEVICE WAS PATENT WITH NO SEPARATION, MIGRATION OR DEVICE INTEGRITY ISSUES. FOLLOW-UP SHOWED THAT THE ENDOLEAK WAS NOT RESOLVED BUT NO OTHER TREATMENT WAS PLANNED. 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. THE IMAGES WERE NOT RETURNED FOR EVALUATION AS 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/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 USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. ACCORDING TO THE IFU (INSTRUCTIONS FOR USE), ENDOLEAK, AORTIC RUPTURE AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ZDEG IMPLANTATION. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. BASED ON THE REPORTED INFORMATION, IT IS ASSUMED THAT THE REPORTED TYPE 1B ENDOLEAK RELATED TO ZDEG, WHICH WAS A RESULT OF THE STAGED PROCEDURE, WHERE CMD WAS NOT IMPLANTED WITHIN THE ZDEG BUT FOLLOWED THE ZDEG WITHOUT OVERLAP DUE TO CMD COULD NOT BE INSERTED HIGH ENOUGH, RESULTING IN FAILURE OF THE BRANCHED CMD TO SEAL. UNTREATED TYPE 1B ENDOLEAK PRESUMABLY COULD LEAD TO THE AORTIC RUPTURE CAUSING HEMOTHORAX AND CARDIAC COMPRESSION ASSOCIATED WITH BILATERAL PULMONARY EDEMA AND LED TO THE PATIENT´S DEATH. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AS THE COMPLAINT FALLS WITHIN THE SCOPE OF AN ONGOING INTERNAL ACTION. 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 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). H10) RELATED REPORT NUMBERS: (B)(4). DUE TO ADDITIONAL INFORMATION RECEIVED ON 18JUL2025 THE EVENT IS NO LONGER CONSIDERED REPORTABLE TO FDA AS NOTHING INDICATES DEVICE DEFICIENCY OR MALFUNCTION. 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 ACCORDING TO STUDY (WCE-1616: ZENITH TX2 DISSECTION W/PRO-FORM AND Z-TRAK PLUS (ZDEG)): ON (B)(6) 2025, 1112 DAYS POST PROCEDURE THE SITE HAS REPORTED DEATH OF PATIENT. PER THE SITE: ¿PATIENT SUFFERING FROM A LEAK FROM AN ENDOVASCULAR AORTIC PROTHESIS CAUSING HAEMOTHROAX AND CARDIAC COMPRESSION ASSOCIATED WITH BILATERAL PULMONARY EDEMA. COLLEGIAL DECISION TO PROVIDE COMFORT CARE IN THE ABSENCE OF ANY REALISTIC THERAPEUTIC OPTION. NO OTHER INFORMATION IS AVAILABLE AND THERE ARE QUERIES PENDING REQUESTING THIS EVENT BE REPORTED AS AN ADVERSE EVENT AND FOR THE SITE TO EVALUATE RELATIONSHIP OF DEVICE. PATIENT OUTCOME: DUE TO THE LEAK FROM THE ENDOVASCULAR AORTIC PROTHESIS, THIS CAUSED HEMOTHORAX AND CARDIAC COMPRESSION ASSOCIATED WITH BILATERAL PULMONARY EDEMA. NO REALISTIC TREATMENT OPTION AND PATIENT PROVIDED COMFORT CARE UNTIL DEATH.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED ON 16JUL2025: THE SITE HAS RELATED THE DEATH TO PREEXISTING CONDITION PRIOR TO PROCEDURE AND PRIMARY DISEASE PROGRESSION. THE SITE HAS STATED THE CAUSE OF DEATH: "HAEMOTHORAX AND CARDIAC COMPRESSION FOLLOWING A LEAK FROM AN ENDOVASCULAR AORTIC PROTHESIS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704756 | ZENITH® TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G23183 | E4185611 | 00827002231832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Death |