AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
Report
- Report Number
- 2017233-2019-00590
- Event Type
- Malfunction
- Date Received
- August 2, 2019
- Date of Event
- July 4, 2019
- Report Date
- May 6, 2020
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
IT APPEARS THAT COMPONENTS FROM TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM USED IN THE PROCEDURE, TGMR404010E/19980176 AND TGM343415E/17415819 WERE RETURNED TO GORE. AN ENGINEERING INVESTIGATION WAS PERFORMED AND IT WAS FOUND THAT THE RETURNED SECONDARY DEPLOYMENT LINE (SDL) ATTACHED TO THE SECONDARY DEPLOYMENT HANDLE MEASURED 156CM FROM THE HANDLE. THIS IS LONGER THAN WHAT IS EXPECTED FOR THE SDL LENGTH FOR A FULLY DEPLOYED 40X40X10 CMDS DEVICE. THE LENGTH OF THE RETURNED SDL SUGGESTS THAT THE INCORRECT SECONDARY DEPLOYMENT HANDLE WAS RETURNED, THEREFORE THE EVENT DESCRIPTION COULD NOT BE CONFIRMED. A ROOT CAUSE FOR SECONDARY DEPLOYMENT NOT OCCURRING CANNOT BE DETERMINED WITH THE CURRENTLY AVAILABLE INFORMATION. IT WAS CONFIRMED TO GORE THAT AT THE TIME OF DEVICE COMPONENT PICKUP AT THE FACILITY, ALL AVAILABLE PARTS BELONGING TO THE TGMR404010E/19980176 AND THE TGMR404015E/20000758 COMPONENTS HAD BEEN COLLECTED. THERE ARE NO FURTHER DEVICE COMPONENTS AVAILABLE FOR INVESTIGATION.
H6: CODE 22 - ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO: DEPLOYMENT FAILURE.
B5: CORRECTED EVENT DESCRIPTION.
B6: UPDATED IMAGING EVALUATION RESULTS.
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM OF THE DESCENDING THORACIC AORTA MEASURING 10 MM IN DIAMETER AND WAS THEREFORE IMPLANTED WITH THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THE CASE WAS PERFORMED WITHOUT GORE SUPPORT. IT WAS PLANNED TO UTILIZE A TGM343415E AS A PROXIMAL COMPONENT AND A TGMR404015E AS A DISTAL COMPONENT. THE DESCENDING THORACIC AORTA WAS THE INTENDED TREATMENT LOCATION WITH THE TGMR404015E COMPONENT EXTENDING TO THE PATIENT¿S CELIAC TRUNK. FOLLOWING THE PLACEMENT OF THE TGM343415E COMPONENT AT THE INTENDED LOCATION, THE SECOND TGMR404015E COMPONENT WAS OBSERVED DURING THE INITIAL DEPLOYMENT TO HAVE MOVED PROXIMALLY FOR ABOUT 10 MM AND INTO THE ANEURYSM SAC. REPORTEDLY, THE MOVEMENT WAS DUE TO THE EXTENT OF THE ANEURYSM DIAMETER AND THE SHORT DISTAL NECK. TO REGAIN THE SEAL ZONE DISTALLY TOWARDS THE CELIAC TRUNK, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT TGMR404010E WAS IMPLANTED AS A THIRD DEVICE. IT APPEARED HOWEVER, THAT DURING SECONDARY DEPLOYMENT, NO PART OF THE DEVICE OPENED TO FULL DIAMETER AND THE ENTIRE DEVICE REMAINED AT 50% OF ITS FULL DIAMETER FOLLOWING INITIAL DEPLOYMENT. RESISTANCE OR A BREAKAGE OF THE DEPLOYMENT LINE DURING SECONDARY DEPLOYMENT WERE NOT REPORTED. ALTHOUGH THE DEVICE HAD NOT OPENED FULLY, THE PHYSICIAN WAS ABLE TO REMOVE THE LOCKWIRE HANDLE AND THE ANGULATION ASSEMBLY AT THAT STAGE, ENABLING THE DEVICE BEING DETACHED FROM THE DEVICE CATHETER. THE PHYSICIAN SUBSEQUENTLY USED A BALLOON IN AN ATTEMPT TO AID THE TGMR404010E STENT GRAFT TO OPEN FULLY, WHICH RESULTED IN ONLY THE PROXIMAL PART ACHIEVING FULL DEPLOYMENT WHILE THE DISTAL PART DID NOT. A SLIGHT TYPE 1B ENDOLEAK WAS NOTICED DURING FINAL IMAGING DUE TO THE INCOMPLETE DEPLOYMENT. THE PATIENT TOLERATED THE PROCEDURE.
THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS.
THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ANEURYSM OF THE DESCENDING THORACIC AORTA MEASURING 10 MM IN DIAMETER AND WAS THEREFORE IMPLANTED WITH THREE GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THE CASE WAS PERFORMED WITHOUT GORE SUPPORT. IT WAS PLANNED THAT THE PATIENT SHOULD RECEIVE A TGM343415E COMPONENT PROXIMALLY RIGHT DISTAL TO THE LEFT SUBCLAVIAN ARTERY AS WELL AS A TGMR404015E COMPONENT DISTALLY IN CLOSE APPROXIMATION TO THE CELIAC TRUNK TO EXCLUDE THE ANEURYSM. FOLLOWING THE PLACEMENT OF THE TGM343415E COMPONENT AT THE INTENDED LOCATION, THE SECOND TGMR404015E COMPONENT WAS OBSERVED DURING THE INITIAL DEPLOYMENT TO HAVE MOVED FOR ABOUT 10 MM AND INTO THE ANEURYSM SAC. REPORTEDLY, THIS PROXIMAL MOVEMENT WAS DUE TO THE EXTENT OF THE ANEURYSM DIAMETER AND THE SHORT DISTAL NECK. FURTHERMORE, IT APPEARED THAT DURING SECONDARY DEPLOYMENT, NO PART OF THE DEVICE OPENED TO FULL DIAMETER AND THE ENTIRE DEVICE REMAINED AT 50% OF ITS FULL DIAMETER FOLLOWING INITIAL DEPLOYMENT. RESISTANCE OR A BREAKAGE OF THE DEPLOYMENT LINE DURING SECONDARY DEPLOYMENT WERE NOT REPORTED. HOWEVER, AND ALTHOUGH THE DEVICE HAD NOT OPENED FULLY, THE PHYSICIAN WAS ABLE TO REMOVE THE LOCKWIRE HANDLE AND THE ANGULATION ASSEMBLY AT THAT STAGE, ENABLING THE DEVICE BEING DETACHED FROM THE DEVICE CATHETER. THE PHYSICIAN SUBSEQUENTLY USED A BALLOON IN AN ATTEMPT TO AID THE TGMR404015E STENT GRAFT TO OPEN FULLY, WHICH RESULTED IN ONLY THE PROXIMAL PART ACHIEVING FULL DEPLOYMENT WHILE THE DISTAL PART DID NOT. TO GAIN ADDITIONAL SEAL ZONE DISTALLY TOWARDS THE CELIAC TRUNK, A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS TGMR404015E WAS IMPLANTED AS A THIRD DEVICE. A SLIGHT TYPE 1B ENDOLEAK WAS NOTICED DURING FINAL IMAGING DUE TO THE FIRST TGMR404015E NOT DEPLOYING FULLY AT ITS DISTAL PART. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648930 | AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL) | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 19980176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization |