GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2025-06084
- Event Type
- Injury
- Date Received
- April 17, 2025
- Date of Event
- June 4, 2024
- Report Date
- July 1, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION SECTION D. CORRECTION - THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO REOPERATION.
THE GORE®¿TAG®¿THORACIC BRANCH ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES THAT ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO PSEUDOANEURYSM, STENT GRAFT MIGRATION, STENT GRAFT INFECTION. 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.
WAHIDI R, KINDELL D, KACHROO P, OHMAN JW. AORTIC RUPTURE DURING TRANSCATHETER AORTIC VALVE REPLACEMENT REQUIRING EMERGENT THORACIC ENDOVASCULAR AORTIC REPAIR AND ENDOGRAFT INFECTION REQUIRING ENDOGRAFT EXPLANT. J VASC SURG CASES, INNOV TECH. 2025;11(3):101746. DOI: 10.1016/J.JVSCIT.2025.101746. SUMMARY: THIS IS A CASE REPORT OF A 58-YEAR-OLD MAN WITH HISTORY OF CORONARY ARTERY DISEASE, CONGESTIVE HEART FAILURE, END STAGE RENAL DISEASE ON PERITONEAL DIALYSIS AND SEVERE AORTIC STENOSIS WITH PREVIOUS PERCUTANEOUS CORONARY INTERVENTION WAS SCHEDULED TO UNDERGO TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE PROCEDURE WAS COMPLICATED BY VALVE DISLODGEMENT AND THORACIC AORTIC RUPTURE IMMEDIATELY DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE PATIENT UNDERWENT EMERGENT THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WITH OVERLAPPING 34X100 MM AND 31X100 MM GORE®TAG®CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, EXTENDING FROM ZONE 2 TO ZONE 5 WITH LEFT SUBCLAVIAN COVERAGE. POSTOPERATIVELY, HE DEVELOPED LEFT UPPER EXTREMITY ISCHEMIA FOR WHICH HE UNDERWENT LASER FENESTRATION AND STENTING OF HIS LEFT SUBCLAVIAN ARTERY ON POST OP DAY 1. ON POST OP DAY 2, AN EMERGENT SUBXIPHOID PERICARDIAL WINDOW WAS REQUIRED TO RELIEVE CARDIAC TAMPONADE. AT UNKNOWN TIMEFRAME POST OP [LESS THAN 7 MONTHS], HE UNDERWENT A PACEMAKER PLACEMENT AT A DIFFERENT FACILITY DUE TO DEVELOPMENT OF SECOND-DEGREE AV HEART BLOCK. AT SEVEN MONTHS AFTER HIS PROCEDURE, HE PRESENTED WITH HEMOPTYSIS AND CT REVEALED TEVAR MIGRATION WITH PERIAORTIC HEMATOMA VS PSEUDOANEURYSM AND CONCERN FOR AORTOBRONCHIAL FISTULA [ABF]. HE HAD EMERGENT PROCEDURE, AND THE LESION WAS COVERED WITH A TAPERED 31X26 GORE®TAG®THORACIC BRANCH ENDOPROSTHESIS. THE PREVIOUS TEVAR WAS RELINED WITH A 34 MM GORE®TAG®THORACIC BRANCH ENDOPROSTHESIS; NOTABLY, HIS PRIOR LEFT SUBCLAVIAN STENT HAD BEEN THROMBOSED CHRONICALLY WITHOUT EVIDENCE OF LEFT UPPER EXTREMITY ISCHEMIA AND WAS, THEREFORE, COVERED. BRONCHOSCOPY REVEALED PERSISTENT POOLING OF BLOOD IN THE SUPERIOR SEGMENT OF THE LEFT LOWER LOBE CONCERNING FOR ABF. BLOOD CULTURES POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS EPIDERMIDIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED CONCERNING 1.7CM VEGETATION ON THE AORTIC VALVE REPLACEMENT [AVR]. A PLANNED 3 DAY STAGED OPERATIVE INTERVENTION WAS PERFORMED. THE FIRST STAGE WAS A STERNOTOMY, AND THE PACEMAKER WAS EXPLANTED AND GROSSLY INFECTED TAVR WAS NOTED WITH ASSOCIATED AORTIC ROOT ABSCESS. THE AORTIC VALVE WAS EXPLANTED, AND NEW VALVE WAS PLACED. THE AORTIC ROOT WAS RECONSTRUCTED WITH BOVINE PATCH. THE SECOND STAGE, A LEFT CAROTID-SUBCLAVIAN TRANSPOSITION WAS PERFORMED IN PREPARATION FOR DISTAL THORACIC AORTA LIGATION. THE THIRD STAGE, A LEFT POSTEROLATERAL THORACOTOMY WAS PERFORMED. THE DESCENDING AORTA WAS LIGATED PROXIMAL TO THE SUPRACELIAC GRAFT ANASTOMOSIS AND COVERED WITH A BOVINE PERICARDIUM PATCH. THE DESCENDING AORTA WAS ENTERED AND THE TEVARS EXPLANTED AND SENT FOR CULTURE ALONG WITH AORTIC TISSUE. CULTURES FROM TEVARS AND AORTIC TISSUE WERE POSITIVE FOR METHICILLIN-RESISTANT S. EPIDERMIDIS, AND THE PATIENT WAS CONTINUED ON A COURSE OF VANCOMYCIN FOR 6 WEEKS WITH LIFELONG ORAL SUPPRESSION. THE PATIENT HAD A REINTUBATION WITH TRACHEOSTOMY PLACEMENT, AND HE WAS TRANSITIONED TO HEMODIALYSIS AND DISCHARGED TO EXTENDED CARE FACILITY ON DAY 71. THE AUTHOR NOTED THAT INFECTED TEVARS OFTEN CLINICALLY MANIFEST AS NONSPECIFIC, PERSISTENT CONSTITUTIONAL SYMPTOMS, OR AS IN THIS CASE, MAY PRESENT AFTER FISTUALIZATION - AORTOBRONCHIAL OR AORTOESOPHAGEAL HAS OCCURRED WITH ASSOCIATED HEMOPTYSIS OR HEMATEMESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111642 | GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | Required Intervention| H |