ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2026-00053
- Event Type
- Malfunction
- Date Received
- March 25, 2026
- Date of Event
- October 3, 2020
- Report Date
- May 27, 2026
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- MIH
- UDI-DI
- 00827002242791
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER 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 REF# (B)(4). BASED ON ADDITIONAL INFORMATION RECEIVED THE ZDEG DEVICE WAS IMPLANTED IN ZONE 4 AND THE LSA WAS NOT COVERED BY THE ZDEG GRAFT WHY THE ENTRY TEAR IS ASSESSED TO BE NOT RELATED TO THE IMPLANTED ZDEG. IT IS THEREFORE CONCLUDED, THAT THE ZDEG WAS NOT RELATED TO THE REPORTED EVENT. CONSEQUENTLY, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE UNDER THE REQUIREMENTS OF FDA 21 CFR PART 803. 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 REF # (B)(4). . G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): 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.
ADDITIONAL INFORMATION RECEIVED 26MAR2026: THE SITE HAD CHANGED THE TYPE IA ENDOLEAK TO AN UNKNOWN ENDOLEAK ON THE 6M IMAGING.
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: WCE-1616: ZENITH TX2 DISSECTION W/PRO-FORM AND Z-TRAK PLUS (ZDEG): ON (B)(6) 2020, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR FOR AN AORTIC DISSECTION VIA ULTRASOUND GUIDED PERCUTANEOUS RIGHT FEMORAL ARTERY UNDER GENERAL ANESTHESIA. THE PROXIMAL ZONE OF GRAFT IMPLANTATION WAS ZONE 4. THE PROXIMAL LOCATION OF DISSECTION WAS WITHIN LEFT SUBCLAVIAN (LSA) AND DISTAL LOCATION OF DISSECTION WAS THE DESCENDING AORTA, DISTAL TO LSA. THE THORACIC AND ABDOMINAL FALSE LUMEN WERE COMPLETELY THROMBOSED. THE PROCEDURE ANGIOGRAPHY REPORTED THAT THE STUDY DEVICE WAS PATENT. THERE WAS NO SEPARATION, EVIDENCE OF DEVICE INTEGRITY ISSUES AND NO ENDOLEAKS PRESENT. ON (B)(6) 2020, THREE DAYS POST PROCEDURE, THE FOLLOW-UP BLOOD WORK AND CLINICAL ASSESSMENT WERE COMPLETED. THE COMPUTED TOMOGRAPHY (CT) IMAGING WAS NOT PROVIDED ON THIS DATE. ON UNKNOWN DATE (B)(6) 2020, THE SITE REPORTED DYSPNEA ON EXERTION. NO TREATMENT WAS DONE FOR THIS EVENT. THE EVENT WAS CONSIDERED NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. THE SITE NOTED THAT THERE WAS NO PRE-EXISTING OR OTHER CONDITION CAUSE OR CONTRIBUTE TO THIS EVENT. NO DEVICE DEFICIENCY WAS NOTED. THIS EVENT REMAINS ONGOING. ON (B)(6) 2020, 38 DAYS POST PROCEDURE, THE 30-DAY FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT REVEALED NO GROWTH OF DISSECTION AND NO NEW DEVELOPMENT OF NEW ENTRY TEAR. THE THORACIC AND ABDOMINAL FALSE LUMEN WERE COMPLETELY THROMBOSED. THE CT SHOWED ALL VESSELS AND THE STUDY DEVICE WERE PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES AND NO ENDOLEAKS. ON (B)(6) 2020, 47 DAYS POST PROCEDURE, THE 30-DAY FOLLOW UP CLINICAL ASSESSMENT WAS COMPLETED. THE SITE NOTED THAT BLOOD WORK WAS NOT COMPLETED AS IT WAS NOT REQUIRED BY THE SURGEON. ON (B)(6) 2020, 111 DAYS POST PROCEDURE, THE SITE REPORTED A TYPE II ENDOLEAK (ORIGINATING FROM ACCESSORY VESSELS). NO TREATMENT WAS DONE AT TIME OF EVENT. THE SITE CONSIDERED THE EVENT NOT RELATED TO THE STUDY DEVICE OR THE STUDY PROCEDURE. THE SITE STATED ¿COLLATERAL¿ AS A PRE-EXISTING, OTHER CONDITION OR CONTRIBUTE TO THIS EVENT. NO DEVICE DEFICIENCY WAS NOTED BY SITE. THE SITE CONSIDERED THIS EVENT ONGOING. ON (B)(6) 2020, 113 DAYS POST PROCEDURE, THE SIX-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ANTEGRADE PROGRESSION/GROWTH OF THE DISSECTION WITHIN THE LSA. THE PROXIMAL LOCATION OF THE DISSECTION IS WITHIN THE LSA AND THE DISTAL LOCATION OF DISSECTION IS AT THE DESCENDING AORTA, DISTAL TO LSA. THE THORACIC FALSE LUMEN WAS PATENT WITH A TYPE IA (PROXIMAL) ENDOLEAK. THE ABDOMINAL FALSE LUMEN WAS COMPLETELY THROMBOSED. THE CT REVEALED THE INNOMINATE/BRACHIOCEPHALIC, LEFT COMMON CAROTID (LCC), LEFT SUBCLAVIAN (LSA), CELIAC, SUPERIOR MESENTERIC (SMA), AND RIGHT AND LEFT RENAL WERE PATENT, AS WELL AS THE STUDY DEVICE. VESSEL PATENCY FOR THE RIGHT AND LEFT COMMON ILIACS AND RIGHT AND LEFT INTERNAL ILIAC WERE UNKNOWN. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 292 DAYS POST PROCEDURE, THE 12-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT REVEALED NO GROWTH OF DISSECTION AND NO NEW DEVELOPMENT OF NEW ENTRY TEAR. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED AT THE COLLATERAL ¿BRONCHIC ARTERY¿. THE ABDOMINAL FALSE LUMEN WAS COMPLETELY THROMBOSED. THE CT SHOWED ALL VESSELS AND THE STUDY DEVICE WERE PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES AND NO ENDOLEAKS. ON (B)(6) 2021, 299 DAYS POST PROCEDURE, THE 12-MONTH CLINICAL ASSESSMENT WAS COMPLETED. THE SITE NOTED THAT BLOOD WORK WAS NOT COMPLETED AS IT WAS NOT REQUIRED BY THE SURGEON. THE TWO-YEAR CLINICAL ASSESSMENT, BLOOD WORK AND CT IMAGING WAS NOT COMPLETED. PATIENT OUTCOME: THE PATIENT WAS WITHDRAWN FROM THE STUDY ON 31OCT2022, WHICH WAS DUE TO PHYSICIAN DECISION TO EXIT PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532046 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G24279 | E3941538 | 00827002242791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |