GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2025-06403
- Event Type
- Malfunction
- Date Received
- July 10, 2025
- Date of Event
- June 12, 2025
- Report Date
- October 10, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- UDI-DI
- 00733132638581
- PMA / PMN Number
- P040043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3: DEVICE EVALUATED BY MANUFACTURER: PROVIDED RESPONSE "YES". CORRECTION: THE GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF 2233 STATED IN THIS REPORT WAS SUBMITTED UNDER MFR # 3007284313-2025-04098.
ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE REMAINS IMPLANTED. A DEVICE EVALUATION COULD THEREFORE NOT BE PERFORMED. D9: PROVIDED ADDITIONAL INFORMATION. IMAGING EVALUATION SUMMARY: MEDICAL IMAGES WERE RETURNED TO GORE. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: O ONE TIME-POINT IS PROVIDED FOR EVALUATION: PRE-IMPLANTATION CTA DATED (B)(6) 2025. FIVE RADIOGRAPHIC JPEG IMAGES ARE ALSO PROVIDED BY THE FSA. PRE-IMPLANTATION CTA DATED (B)(6) 2025 SHOWS: O IMAGES SHOW THERE IS A PAU ON THE INNER CURVE OF THE THORACIC AORTIC ARCH. O LENGTH FROM THE LSA TO THE LESION APPEARS TO BE ~4.8MM. O LENGTH FROM THE LCCA TO THE LESION APPEARS TO BE ~ 2.7CM, BY OUTER CURVE LENGTH. O DIAMETERS APPEAR TO RANGE FROM ~27.7MM ¿ 28.4MM, IN THE PROXIMAL LANDING ZONE. O LENGTH OF THE LESION APPEARS TO BE ~2.6CM BY OUTER CURVE LENGTH. O DIAMETERS RANGE FROM 28MM ¿ 31.3MM, IN THE DISTAL LANDING ZONE UTILIZING A 10CM DEVICE. O DICOM FINDINGS APPEAR TO ALIGN WITH THE JPEG IMAGES SENT IN BY THE FSA. THE IMAGES PROVIDED DO NOT ALLOW FOR EVALUATION IN RELATION TO THE REPORTED COMPLAINT. PRODUCT EVALUATION SUMMARY: THE DELIVERY SYSTEM OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TGM343410E/(B)(6) WAS RETURNED TO GORE. THE DEVICE EVALUATION SHOWED THE FOLLOWING: O THERE WAS NO DISCERNIBLE LENGTH OF SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB. THE CORE AND OUTERWRAP OF THE BROKEN SDL END APPEAR TO HAVE EXPERIENCED TENSILE FORCES AND ARE NOT INDICATIVE OF A CLEAN CUT. THE OBSERVATIONS OF THE DEVICE EVALUATION SUPPORT THE EVENT DESCRIPTION¿S REPORT OF THE SECONDARY DEPLOYMENT LINE BREAKING. O THE REPORTED FAILURE TO DEPLOY (SECONDARY DEPLOYMENT LINE/SLEEVE) WAS CONFIRMED THROUGH THE DEVICE EVALUATION. THE DEVICE MOVEMENT DISTALLY OF INTENDED POSITION AFTER DEPLOYMENT COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. O THE CAUSE OF THE SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. BASED ON THE LOCATION OF THE FIBER FAILURE AT THE HANDLE CONNECTOR, THE DEPLOYMENT LINE BREAKING IS LIKELY DUE TO SOME TYPE OF RESISTANCE IN THE DEPLOYMENT LINE, BUT THE SPECIFIC CAUSE OF RESISTANCE COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. BASED ON THIS INVESTIGATION, A MANUFACTURING DEFICIENCY WAS NOT ABLE TO BE CONFIRMED THROUGH THE DEVICE EVALUATION. EMDR SECTION H6: CODES HAVE BEEN ADDED/UPDATED TO REFLECT THE EXTENT OF THE INVESTIGATION PERFORMED. H6, HEALTH EFFECT ¿ CLINICAL CODE: REPLACED CODE E2403 WITH E2008. H6, HEALTH EFFECT ¿ IMPACT CODE: ADDED CODE F1908. H6, MEDICAL DEVICE PROBLEM CODE: ADDED CODES A150101, A010402, A0106. H6, COMPONENT CODE: REPLACED CODE G07003 WITH G04044. H6, TYPE OF INVESTIGATION: ADDED CODES B01, B14, B11. H6, INVESTIGATION FINDINGS: REPLACED CODE C21 WITH C0706. H6, INVESTIGATION CONCLUSIONS: REPLACED CODE D16 WITH D15. THE GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF 2233 STATED IN THIS REPORT WAS SUBMITTED UNDER MFR# 2017233-2025-06403.
A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. H6, TYPE OF INVESTIGATION, CODE B15: GORE IS CURRENTLY INVESTIGATING MEDICAL IMAGES RECEIVED. 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.
IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC PENETRATING ULCER (PAU) OF THE INNER CURVE SITUATED DIRECTLY BEHIND THE LEFT SUBCLAVIAN ARTERY (LSA). AS THE THORACIC AORTIC ARTERY MEASURED 28 MM, A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICE TGM343410 WAS SELECTED. IT WAS PLANNED TO OVERSTENT THE LSA WITHOUT DEBRANCHING AND WITH A LANDING ZONE AT THE LEFT CAROTID ARTERY. USING A LUNDERQUIST GUIDE WIRE AND A GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF 2233, THE TGM343410 STENTGRAFT WAS INSERTED AND ADVANCED TO THE INTENDED LOCATION VIA THE RIGHT SIDE. TO PREPARE DEPLOYMENT, THE DEVICE WAS SECURED AT THE SHEATH VALVE AND FORWARD PRESSURE WAS EXERTED TO THE WIRE TO ENSURE THE DEVICE WAS POSITIONED AGAINST THE OUTER AORTIC CURVE. AFTER REMOVING THE PRIMARY DEPLOYMENT HANDLE, THE DEVICE OPENED FROM PROXIMAL TO DISTAL TO ITS INTERMEDIATE DIAMETER AS TYPICAL. HOWEVER, WHEN ATTEMPTING TO REMOVE THE SECONDARY DEPLOYMENT HANDLE FOR THE DEVICE TO OPEN TO FULL DIAMETER, THE PHYSICIAN REPORTEDLY FELT RESISTANCE, REALIZING THAT THE BLUE LINE AT ITS MOUNTING HAD JUST BROKE. SUBSEQUENTLY, THE DEPLOYMENT LINE ACCESS HATCH OF THE DEPLOYMENT BACKUP MECHANISM WAS REMOVED AND THE DEPLOYMENT LINE WAS CLAMPED. REPORTEDLY, IT WAS THEN ATTEMPTED TO PULL THE LINE WITH THE CLAMP, BUT THIS WAS STOPPED IMMEDIATELY WHEN UNDER FLUOROSCOPY THE PROXIMAL PORTION OF THE DEVICE WAS SEEN TO MOVE. ADDITIONALLY, THE INLYING PIGTAIL CATHETER WAS REMOVED BUT ANOTHER SLIGHT PULL ON THE LINE WAS EQUALLY UNSUCCESSFUL. NEXT, A 12 FR GORE® DRY SEAL FLEX INTRODUCER SHEATH WAS ADDITIONALLY INSERTED ON THE LEFT SIDE AND SEVERAL CATHETERS WERE USED TO CANNULATE THE DEVICE. IN DOING SO THE RIGHT SHEATH SLIPPED OUT OF THE PATIENT, WHICH NECESSITATED PACKED RED BLOOD CELL TRANSFUSION DUE TO THE PATIENT EXPERIENCING AN ESTIMATED BLOOD LOSS BETWEEN 0.5 AND 1 LITER. WHEN THE SHEATH WAS INSERTED BACK INTO THE PATIENT, THE ENDOPROSTHESIS WAS REPORTED TO HAVE MOVED SLIGHTLY TOWARDS DISTAL. FOLLOWING CANNULATION, THE ENDOPROSTHESIS WAS DILATED FROM DISTAL TO PROXIMAL WITH A MEDTRONIC RELIANT¿ STENT GRAFT BALLOON CATHETER AB 46 AND THE DISTAL PORTION OF DEVICE IMMEDIATELY OPENED TO FULL DIAMETER AS WELL AS SLIGHTLY MORE THAN HALF OF THE OVERALL LENGTH OF THE DEVICE, ALLOWING THE DEVICE FOR FIXATION IN THE VESSEL WALL. NEXT, THE PHYSICIAN ATTEMPTED TO DILATE THE DEVICE PORTIONS AT THE PROXIMAL END AND IN THE AORTIC ARCH, BUT ALMOST NO DILATION WAS DISCERNIBLE, THUS THE ENDOPROSTHESIS REMAINED NARROW. THERE WAS ALSO NO SUCCESS WHEN AGAIN PULLING THE BLUE DEPLOYMENT LINE SEVERAL TIMES, BOTH WITH AND WITHOUT BALLOON FIXATION, AND IT APPEARED UNDER FLUOROSCOPY IMAGING THAT THE LINE WAS STUCK AT THE PROXIMAL END OF THE DEVICE, AS THERE WAS SLIGHT MOVEMENT. TO PROCEED WITH THE PROCEDURE, THE RED LOCKWIRE HANDLE AND THE GREY ANGULATION ASSEMBLY HANDLE WERE REMOVED WITHOUT PROBLEMS AND THE DELIVERY CATHETER WAS RETRACTED. THE BLUE DEPLOYMENT LINE IS NOW FIXED OUTSIDE THE SHEATH WITH A CLAMP, THEREFORE ANOTHER ATTEMPT TO DILATE THE DEVICE AT ITS PROXIMAL END WAS PERFORMED, BUT THERE WAS NO SUCCESS. ANGIOGRAPHY IMAGING FROM THE LEFT SHOWS THE ENDOPROSTHESIS ABOUT 3 CM DISTAL TO THE PLANNED LANDING ZONE WITH THE UNCOVERED STENT STRUTS LOCATED EXACTLY IN THE PAU TO BE TREATED. TO REMEDY THE SITUATION, A SECOND TGM343410E WAS INSERTED INTO THE PATIENT AND IMPLANTED WITH A SATISFACTORY RESULT SHOWING THE PAU SUCCESSFULLY REPAIRED. ENSUING RETRACTION OF THE SHEATH, THE BLUE DEPLOYMENT LINE WAS CUT OFF INSIDE THE VESSEL. THE LINE REMAINS INSIDE THE PATIENT AND IS ATTACHED TO THE TGM343410 DEVICE AT ONE END AND REACHES TO DOWN TO THE PATIENT¿S RIGHT GROIN AT THE OTHER END. AN ABDOMINAL AORTIC ANEURYSM REPAIR WAS ALSO PLANNED DURING THE NEXT WEEKS BUT HAS BEEN PUT ON HOLD FOR THE TIME BEING. THE PATIENT TOLERATED THE PROCEDURE AND WAS REPORTED TO HAVE BEEN WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1729249 | GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | 00733132638581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Male | Required Intervention | SEE B5, EVENT DESCRIPTION. |