ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
Report
- Report Number
- 3002808486-2025-00191
- Event Type
- Injury
- Date Received
- September 3, 2025
- Date of Event
- February 27, 2019
- Report Date
- May 8, 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). D4) CATALOG# IS UNKNOWN BUT IS EITHER ZDEG-P-38-154-PF OR ZDEG-P-30-142-PF. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P180001. INVESTIGATION IS STILL IN PROGRESS. 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.
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.
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: 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. ON (B)(6) 2019, FIVE 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 COMPLETELY THROMBOSED AND THE ABDOMINAL FALSE LUMEN WAS PARTIALLY THROMBOSED 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) 2019, 291 DAYS POST PROCEDURE, THE SIX-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THE ABDOMINAL FALSE LUMEN FLOW WAS PARTIALLY THROMBOSED WITH TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2020, 437 DAYS POST PROCEDURE, THE 12-MONTH FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THE ABDOMINAL FALSE LUMEN FLOW WAS PARTIALLY THROMBOSED WITH TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2021, 704 DAYS POST PROCEDURE, THE TWO-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE CT SHOWED ALL VESSELS WERE PATENT, INCLUDING THE STUDY DEVICE. THE THORACIC FALSE LUMEN WAS PARTIALLY THROMBOSED WITH TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THE ABDOMINAL FALSE LUMEN FLOW WAS PARTIALLY THROMBOSED WITH TYPE IB ENDOLEAK AT THE PRIMARY TEAR. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2022, 1130 DAYS POST PROCEDURE THE THREE-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE SITE HAS NOT COMPLETED THE DATA AND HAS ONLY NOTED THE STUDY DEVICE WAS PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2023, 1480 DAYS POST PROCEDURE THE FOUR-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE SITE HAS NOT COMPLETED THE DATA AND HAS ONLY NOTED THE STUDY DEVICE WAS PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2024, 1788 DAYS POST PROCEDURE THE FIVE-YEAR FOLLOW-UP CT WITH CONTRAST WAS COMPLETED. THE SITE HAS NOT COMPLETED THE DATA AND HAS ONLY NOTED THE STUDY DEVICE WAS PATENT. THERE WAS NO SEPARATION, EVIDENCE OF MIGRATION OR DEVICE INTEGRITY ISSUES. PATIENT OUTCOME: THE PATIENT WAS EXITED FROM THE STUDY FOLLOWING THE 5-YEAR VISIT AS THE FINAL STUDY VISIT WAS COMPLETED.
ADDITIONAL INFORMATION RECEIVED 01OCT2025: FIRST IMPLANTATION OF THE ZDEG-P-30-142, THEN ZDEG-P-38-154 WITH AN OVERLAP OF TWO STENTS, THEN IMPLANTATION OF THE ZDEG-46-185 AND AFTER IMPLANTATION OF THE NON-COVERED STENT ZDES-46-185 AND AFTER 36-180. CATHETERIZATION OF THE RIGHT RENAL ARTERY, ANGIOPLASTY OF THE FLAP TO DISRUPT THE FLAP INSIDE THE NON-COVERED ZDES AND STENTING OF THE RENAL ARTERY. FINALLY KISSING STENT OF THE AORTIC BIFURCATION WITH NON-COVERED STENT THE PRIMARY ENTRY TEAR WAS LOCATED AT THE LEVEL OF THE ISTHMIC AORTA 74MM AFTER THE SUBCLAVIAN ARTERY ON THE LARGE CURVATURE WITH THE STABILIZE TECHNIQUE ALL THE SECONDARY ENTRY TEAR ARE DISPUTED. ADDITIONAL INFORMATION RECEIVED 02OCT2025: THE PATIENT RECEIVE TREATMENT RELATED TO THE TYPE 1B ENDOLEAK. FIRST EXTENSION OF THE COVERED STENT TO THE COELIAC TRUNK FOR AN ANEURYSMAL EVOLUTION AT THE DISTAL PART OF THE THORACIC AORTA, AND AFTER EMBOLIZATION AT THE DISTAL PART OF THE THORACIC AORTA BECAUSE THE COVERED STENT GRAFT IMPLANTED DISTALLY WAS NOT FULLY APPLIED ON THE DISTAL NECK JUST ABOVE THE CT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238987 | ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | WILLIAM COOK EUROPE | G24286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |