GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2024-05612
- Event Type
- Malfunction
- Date Received
- December 16, 2024
- Date of Event
- September 25, 2024
- Report Date
- March 6, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDED CODE B15 FOR PROVIDED IMAGING ANALYSIS. CORRECTION: UPDATED INVESTIGATION CONCLUSION CODE FROM D1102 TO D15. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: THREE TIME-POINTS AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA¿S DATED ON (B)(6) 2024 AND (B)(6) 2024. POST-IMPLANTATION CTA DATED ON (B)(6) 2024. THE PRE-IMPLANTATION CTA DATED ON (B)(6) 2024 SHOWS: THE LENGTH FROM THE DISTAL LSA BORDER PROXIMAL, TO THE ENTRY TEAR APPEARS TO BE 1.2 CM, BY OUTER CURVE LENGTH. THE DISSECTION APPEARS TO EXTEND THROUGH THE LCI AND POSSIBLY INTO THE LIIA. THE PRE-IMPLANTATION CTA DATED ON (B)(6) 2024 SHOWS: THE LENGTH FROM THE DISTAL LSA BORDER PROXIMAL, TO THE ENTRY TEAR APPEARS TO BE 1.0 CM, BY OUTER CURVE LENGTH. THE DISSECTION APPEARS TO EXTEND THROUGH THE LCI AND INTO THE LIIA. THE POST-IMPLANTATION CTA DATED ON (B)(6) 2024 SHOWS: RECONSTRUCTION IMAGE SHOWS 2 DEVICES ARE IMPLANTED. (TWO PROXIMAL GOLD BANDS ARE IDENTIFIED.) THE DISTAL END OF THE IMPLANTED DEVICE APPEARS TO BE IN THE TRUE LUMEN. THEREFORE, THE DEVICE END IS NARROWED COMPARED TO THE PROXIMAL END DUE TO ANATOMICAL LUMEN RESTRICTION. NO DEVICE COMPRESSION IS IDENTIFIED. THE ENGINEERING EVALUATION SHOWED THE FOLLOWING: A FULL DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. AN IMAGING EVALUATION WAS PERFORMED. THE REPORTED COMPRESSION AND THE REPORTED LACK OF CIRCUMFERENTIAL DEVICE APPOSITION CANNOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. NO ROOT CAUSES FOR THE COMPRESSION OR LACK OF CIRCUMFERENTIAL DEVICE APPOSITION COULD BE IDENTIFIED.
H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE C20 - THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. 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.
ON (B)(6) 2024, PATIENT WAS SEEN IN THE EMERGENCY ROOM FOR PAIN, AND A CAT SCAN REVEALED A TYPE B AORTIC DISSECTION. PHYSICIAN PLANNED TO DO A BYPASS SURGERY, AS PATIENT WAS NOT A CANDIDATE FOR A ZONE 2 TBE CASE, DUE TO LOCATION OF PRIMARY ENTRY TEAR. ON (B)(6) 2024, PATIENT UNDERWENT BYPASS PROCEDURE, IN WHICH A CAROTID-TO-CAROTID BYPASS AND CAROTID TO LSA BYPASS WAS PERFORMED. ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A TYPE B AORTIC DISSECTION, UTILIZING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THESE 2 CTAGAC DEVICES WERE IMPLANTED AT THE INNOMINATE ARTERY. DURING THE PROCEDURE, THE FIRST CTAGAC DEVICE WAS DEPLOYED, AND IT SEEMED TO MOVE DISTALLY FROM THE INTENDED LOCATION, SO ANOTHER CTAGAC DEVICE WAS DEPLOYED. THE SECOND CTAGAC DEVICE WAS NOTED TO BE COMPRESSED AT THE DISTAL END. THE PROCEDURE WAS FINALIZED AND NO FURTHER ISSUES WERE NOTED. PHYSICIAN WILL BE PERFORMING AN ECHO TO DETERMINE IF THERE IS ANY PRESSURE GRADIENT. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, DURING A POST-OP FOLLOW-UP, PATIENT PRESENTED WITH SEVERE AORTIC INSUFFICIENCY. THIS WAS NOT OBSERVED ON (B)(6) 2024. ON (B)(6) 2024, DURING A POST-OP ANGIOGRAM IMAGING REVEALED THE STENTS LOOKED GOOD, AND NO COMPRESSION REMAINED. A DISTAL BIRD'S BEAK WITH NO PRESSURE GRADIENT WAS OBSERVED. A TEE WAS PERFORMED FOR THE AORTIC VALVE AND NOTICED ONE OF THE AORTIC LEAFLETS (LEFT) WAS NOT PERFORMING WELL. PHYSICIAN BELIEVES IT MAY BE RELATED TO THE LUNDERQUIST WIRE, WHEN APPLYING FORWARD PRESSURE ON THE WIRE DURING DEPLOYMENT. ON (B)(6) 2024, PATIENT UNDERWENT ANOTHER PROCEDURE TO REPLACE THE VALVE, AORTIC ROOT, AND SEW A GRAFT TO THE CTAGAC DEVICE. THE CAUSE OF THE COMPRESSION WAS DUE TO THE DEVICE LANDING IN THE PREVIOUS GRAFT WITH A BIRDS BEAK. NO ANATOMICAL FACTORS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2311343 | GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male |