CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS
Report
- Report Number
- 2017233-2024-04984
- Event Type
- Injury
- Date Received
- May 23, 2024
- Date of Event
- July 7, 2017
- Report Date
- May 28, 2024
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CODE C 20: - A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. ACCORDING TO THE CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK AND REOPERATION. PLEASE NOTE THAT THE ARTICLE ¿ASCENDING THORACIC ENDOVASCULAR AORTIC REPAIR WITH CHIMNEY STENT GRAFT TO FREE VEIN CORONARY BYPASS FOR RUPTURED TYPE A AORTIC DISSECTION,¿ JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, 9(2), P. 101067 BY MEHDI TEYMOURI, MANISH MEHTA, PHILIP PATY, MICHAEL LAYDEN, ZACHARY W. KOSTUN AND LALITHAPRIYA JAYAKUMAR PUBLISHED ON NOVEMBER 5, 2022 WAS ATTACHED TO THE REPORT. THE DATE OF EVENT WILL BE USED THE DATE OF THE CTA JULY 7, 2017- WHEN THE ENDOLEAK WAS FOUND. PLEASE NOTE THAT A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE IS REPORTED SEPARATELY. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
THE CODE G04122 WAS CORRECTED FOR THE CODE G07001 AS WE CAN'T CONFIRM THAT THE CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS ATTRIBUTED TO THE GUTTER LEAK. THE STENT WAS NOT USED ALONE. THERE WAS A CHIMNEY GRAFT THAT ALSO PLAYED A ROLE IN THE GUTTER LEAK.
THE ARTICLE ¿ASCENDING THORACIC ENDOVASCULAR AORTIC REPAIR WITH CHIMNEY STENT GRAFT TO FREE VEIN CORONARY BYPASS FOR RUPTURED TYPE A AORTIC DISSECTION,¿ JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS AND TECHNIQUES, 9(2), P. 101067 BY MEHDI TEYMOURI, MANISH MEHTA, PHILIP PATY, MICHAEL LAYDEN, ZACHARY W. KOSTUN AND LALITHAPRIYA JAYAKUMAR PUBLISHED ON NOVEMBER 5, 2022 WAS RECEIVED. THE ARTICLE DESCRIBED THAT HAD PRESENTED TO THE EMERGENCY ROOM WITH TEARING CHEST AND BACK PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) CONFIRMED THE PRESENCE OF ACUTE TAAD (THORACIC AORTIC ANEURYSM AND DISSECTION) WITH A DISSECTION ENTRY TEAR AT THE LEVEL OF THE SINOTUBULAR JUNCTION AND THE PROXIMAL FREE VEIN CIRCUMFLEX BYPASS ANASTOMOSIS. THE DISSECTION WAS LIMITED TO THE ASCENDING THORACIC AORTA AND INVOLVED THE FREE VEIN CIRCUMFLEX CORONARY BYPASS. THE MAXIMUM ASCENDING THORACIC DIAMETER WAS 5.5 CM, AND A FALSE LUMEN THROMBOSIS WAS NOTED. SHE WAS EVALUATED BY CARDIAC SURGERY AND WAS DEEMED INOPERABLE. PATIENT WAS DISCHARGED HOME. DURING THE NEXT 2 WEEKS, THE PATIENT DEVELOPED WORSENING CHEST AND BACK PAIN, AND RECEIVED A REPEAT CTA, WHICH INDICATED A RUPTURED 10- CM ASCENDING TAAD. THE PATIENT¿S CASE WAS DISCUSSED WITH CARDIAC SURGERY, AND THEY CONFIRMED THAT SHE WAS SURGICALLY INOPERABLE. SURGEONS PLANNED AN ENDOVASCULAR ASCENDING THORACIC AORTIC ANEURYSM REPAIR AND WITH A RETROGRADE CHIMNEY STENT GRAFT TO THE FREE VEIN CIRCUMFLEX CORONARY ARTERY BYPASS. ON (B)(6), 2017, THE PATIENT UNDERWENT EMERGENT ENDOVASCULAR RUPTURED ASCENDING THORACIC AORTIC ANEURYSM REPAIR USING A CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS (45MM X10CM) WITH A CHIMNEY STENT GRAFT TO A FREE VEIN CORONARY BYPASS THAT ORIGINATED FROM THE ASCENDING THORACIC AORTA. ON THE IMMEDIATE POSTOPERATIVE CTA, A GUTTER ENDOLEAK WAS IDENTIFIED ACROSS THE LONG CHIMNEY TO FREE VEIN CIRCUMFLEX CORONARY BYPASS, AND THE PATIENT UNDERWENT PERCUTANEOUS FEMORAL ARTERY ACCESS AND COIL EMBOLIZATION. A 5F BERNSTEIN GUIDE CATHETER AND GLIDE WIRE WERE USED TO ACCESS THE GUTTER, THE CATHETER WAS ADVANCED INTO THE THORACIC ANEURYSM, AND COIL EMBOLIZATION WAS PERFORMED ACROSS THE LENGTH OF THE 10-CM GUTTER ENDOLEAK USING 15-MM TO 20-MM COILS. THE PROCEDURE WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED HOME ON POSTOPERATIVE DAY 1. AT THE PATIENT¿S LAST FOLLOW-UP AT 4 YEARS POSTOPERATIVELY, CTA HAD CONFIRMED A SIGNIFICANT DECREASE IN THE THORACIC ANEURYSM SIZE AND NO ENDOLEAK. PATIENT NOTED TO HAVE DIED ¿PEACEFULLY IN 2021 FROM NATURAL CAUSES (AFTER A HIP FRACTURE, SHE EVENTUALLY SUCCUMBED TO DETERIORATION IN HER GENERAL MEDICAL CONDITION).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624431 | CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Required Intervention| H| O |