GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
Report
- Report Number
- 2017233-2023-03932
- Event Type
- Malfunction
- Date Received
- May 16, 2023
- Date of Event
- April 18, 2023
- Report Date
- September 6, 2023
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
A REQUEST WAS SENT TO THE PHYSICIAN TO FURTHER CLARIFY THE EVENT. THE PROVIDED ADDITIONAL INFORMATION WAS CAPTURED IN THE EVENT DESCRIPTION. DICOM IMAGING SERIES FOR EVALUATION OF THE REPORTED ISSUE HAVE BEEN REQUESTED FROM THE PHYSICIAN. THE PROVIDED IMAGES CONSISTED OF A HAND-DRAWN CASE PLAN AND PRE-IMPLANT DICOM IMAGING SERIES. NO DICOM IMAGING SERIES OF THE PROCEDURE OR POST-PROCEDURE HAVE BEEN PROVIDED. THEREFORE THE EVENT AS DESCRIBED CANNOT BE EVALUATED BASED ON THE PROVIDED IMAGES. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE AN EVALUATION OF THE ENDOPROSTHESIS COULD NOT BE PERFORMED. THE DELIVERY SYSTEM THE DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION SUMMARY STATES THE FOLLOWING: THE SECONDARY DEPLOYMENT LINE (SDL) THAT REMAINED CONNECTED TO THE SECONDARY DEPLOYMENT KNOB MEASURED APPROXIMATELY 2.9 CM. THE REMAINING LENGTH OF THE SDL FIBER WAS SEPARATED FROM THE DEVICE AND HANDLE AND MEASURED APPROXIMATELY 152.5 CM. THE CORE AND OVERWRAP OF THE FIBER END APPEAR TO BE INDICATIVE OF A CLEAN CUT. THE LENGTH OF THE RETURNED SDL PIECE CONNECTED TO THE HANDLE IS INDICATIVE OF THE LINE BREAKING WITHIN THE HANDLE OF THE DEVICE, SUPPORTING THE PHYSICIAN¿S OBSERVATION OF THE DEVICE REMAINING AT INTERMEDIATE DIAMETER FOLLOWING SECONDARY DEPLOYMENT. SECONDARY DEPLOYMENT NOT FULLY DEPLOYING FROM THE INTERMEDIATE DIAMETER IS LIKELY DUE TO THE SECONDARY DEPLOYMENT LINE BREAKING. THE DEPLOYMENT LINE APPEARS TO HAVE BROKEN DUE TO BEING CUT, BUT THE ROOT CAUSE OF THE CUT SECONDARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED WITH THE CURRENTLY AVAILABLE INFORMATION. DUE TO THE DAMAGE OBSERVED TO THE FIBER, THERE IS POTENTIAL FOR THE FAILURE MODE TO BE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. BASED ON THE EVENT DESCRIPTION AND THE SUBSEQUENT INVESTIGATION WE ARE UNABLE TO DETERMINE THE CAUSE OF THIS INCIDENT AND ASSIGN A ROOT CAUSE.
TYPE OF REPORTABLE EVENT CHANGED TO 'MALFUNCTION.'
D10 CONCOMITANT MEDICAL PRODUCTS: GORE® TRI-LOBE BALLOON CATHETER (CATALOG BCL2645, SN (B)(6)). A REQUEST WAS SENT TO THE PHYSICIAN TO FURTHER CLARIFY THE EVENT. THE PROVIDED ADDITIONAL INFORMATION WAS CAPTURED IN THE EVENT DESCRIPTION THE DEVICE REMAINS IMPLANTED IN THE PATIENT. THEREFORE AN EVALUATION OF THE ENDOPROSTHESIS COULD NOT BE PERFORMED. THE DELIVERY SYSTEM OF THE DEVICE WAS RECEIVED FOR EVALUATION. THE ANALYSIS OF PRODUCTION RECORDS ARE ONGOING. THE ANALYSIS OF THE RECEIVED IMAGES IS ONGOING. 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 THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH A PENETRATING AORTIC ULCER CLOSE TO THE AORTIC ARCH DISTAL TO THE LEFT SUBCLAVIAN ARTERY. A STAGED PROCEDURE WAS PERFORMED TO TREAT THE LESION WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. FIRST, TO ACCOMMODATE THE LANDING ZONE, THE PATIENT HAD BEEN TREATED WITH DEBRANCHING OF THE LEFT SUBCLAVIAN ARTERY. FOUR WEEKS LATER THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEMS WERE IMPLANTED. AS ACCESSORIES A GORE® DRYSEAL FLEX INTRODUCER SHEATH, A LUNDERQUIST DOUBLE CURVED GUIDEWIRE, A PIGTAIL CATHETER (TERUMO), AND A GORE®TRI-LOBE CATHETER WERE USED. DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS ABLE TO POSITION THE DEVICE AT THE LEFT CAROTID ARTERY AT THE PLANNED LANDING ZONE. AFTER TURNING AND REMOVING THE SECONDARY DEPLOYMENT HANDLE, THE PHYSICIAN DETERMINED THAT THE DEVICE HAD NOT FULLY EXPANDED. HE NOTED THAT THERE WAS NO DEPLOYMENT LINE ON THE GREY HANDLE (WITH RED PIN), JUST A VERY SHORT PART OF IT, INDICATING THAT THE DEPLOYMENT LINE HAS BROKEN. THE PHYSICIAN OPENED THE ACCESS HATCH OF THE DEVICE¿S BACK-UP DEPLOYMENT MECHANISM. THE SECONDARY DEPLOYMENT LINE WAS NOT THERE. THE DEVICE WAS STILL IN THE CORRECT POSITION, SO THE PHYSICIAN REMOVED THE RED LOCKWIRE HANDLE AND THE ANGULATION ASSEMBLY HANDLE. THE LOCKWIRE AND THE ANGULATION FIBERS WERE ATTACHED TO THE HANDLES AND COULD BE REMOVED. THEN THEY CAREFULLY REMOVED THE DELIVERY SYSTEM FROM THE PATIENT WITH NO ISSUE. THE PHYSICIAN ATTEMPTED TO BALLOON THE DEVICE WITH THE GORE®TRI-LOBE CATHETER. IT WAS PLANNED TO BALLOON THE DISTAL END OF THE DEVICE FIRST, BUT THE BALLOON WAS ALREADY MOVED MORE PROXIMAL. DURING REPOSITIONING OF THE BALLOON, THE DEVICE STARTED TO MOVE DISTAL. DURING BALLOONING THE DEVICE MOVED FURTHER DISTAL BY 2-3 CM. THE PHYSICIAN WAS ABLE TO FULLY EXPAND THE DEVICE USING THE BALLOON. WHEN REMOVING THE BALLOON FROM THE PATIENT THE DISCONNECTED BLUE DEPLOYMENT LINE STARTED TO COME OUT OF THE VALVE OF THE INTRODUCER SHEATH. THEY SECURED IT WITH A CLAMP AND USED AN ADDITIONAL PIGTAIL GUIDEWIRE TO FULLY REMOVE THE DEPLOYMENT LINE SUCCESSFULLY. TO CORRECT FOR THE MISPLACEMENT OF THE FIRST DEVICE A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS THEN INTRODUCED PROXIMAL TO THE FIRST. THIS DEVICE DEPLOYED WITHOUT COMPLICATION AND LANDED ACCURATELY. FINAL BALLOONING WAS PERFORMED SUCCESSFULLY. FINAL ANGIOGRAPHY SHOWED THAT THE LANDING ZONE WAS AT LEFT CAROTID ARTERY AS INTENDED, EXCLUSION OF THE LESION AND NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.
IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTING WITH A PENETRATING AORTIC ULCER CLOSE TO THE AORTIC ARCH DISTAL TO THE LEFT SUBCLAVIAN ARTERY. A STAGED PROCEDURE WAS PERFORMED TO TREAT THE LESION WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. FIRST, TO ACCOMMODATE THE LANDING ZONE, THE PATIENT HAD BEEN TREATED WITH DEBRANCHING OF THE LEFT SUBCLAVIAN ARTERY. FOUR WEEKS LATER THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEMS WERE IMPLANTED. AS ACCESSORIES A GORE® DRYSEAL FLEX INTRODUCER SHEATH, A LUNDERQUIST DOUBLE CURVED GUIDEWIRE, A PIGTAIL CATHETER (TERUMO), AND A GORE®TRI-LOBE CATHETER WERE USED. DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS ABLE TO POSITION THE DEVICE AT THE LEFT CAROTID ARTERY AT THE PLANNED LANDING ZONE. AFTER TURNING AND REMOVING THE SECONDARY DEPLOYMENT HANDLE, THE PHYSICIAN DETERMINED THAT THE DEVICE HAD NOT FULLY EXPANDED. HE NOTED THAT THERE WAS NO DEPLOYMENT LINE ON THE GREY HANDLE (WITH RED PIN), JUST A VERY SHORT PART OF IT, INDICATING THAT THE DEPLOYMENT LINE HAS BROKEN. THE PHYSICIAN OPENED THE ACCESS HATCH OF THE DEVICE¿S BACK-UP DEPLOYMENT MECHANISM. THE SECONDARY DEPLOYMENT LINE WAS NOT THERE. THE DEVICE WAS STILL IN THE CORRECT POSITION, SO THE PHYSICIAN REMOVED THE RED LOCKWIRE HANDLE AND THE ANGULATION ASSEMBLY HANDLE. THE LOCKWIRE AND THE ANGULATION FIBERS WERE ATTACHED TO THE HANDLES AND COULD BE REMOVED. THEN THEY CAREFULLY REMOVED THE DELIVERY SYSTEM FROM THE PATIENT WITH NO ISSUE. THE PHYSICIAN ATTEMPTED TO BALLOON THE DEVICE WITH THE GORE®TRI-LOBE CATHETER. IT WAS PLANNED TO BALLOON THE DISTAL END OF THE DEVICE FIRST, BUT THE BALLOON WAS ALREADY MOVED MORE PROXIMAL. DURING REPOSITIONING OF THE BALLOON, THE DEVICE STARTED TO MOVE DISTAL. DURING BALLOONING THE DEVICE MOVED FURTHER DISTAL BY 2-3 CM. THE PHYSICIAN WAS ABLE TO FULLY EXPAND THE DEVICE USING THE BALLOON. WHEN REMOVING THE BALLOON FROM THE PATIENT THE DISCONNECTED BLUE DEPLOYMENT LINE STARTED TO COME OUT OF THE VALVE OF THE INTRODUCER SHEATH. THEY SECURED IT WITH A CLAMP AND USED AN ADDITIONAL PIGTAIL GUIDEWIRE TO FULLY REMOVE THE DEPLOYMENT LINE SUCCESSFULLY. TO CORRECT FOR THE MISPLACEMENT OF THE FIRST DEVICE A SECOND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS THEN INTRODUCED PROXIMAL TO THE FIRST. THIS DEVICE DEPLOYED WITHOUT COMPLICATION AND LANDED ACCURATELY. FINAL BALLOONING WAS PERFORMED SUCCESSFULLY. FINAL ANGIOGRAPHY SHOWED THAT THE LANDING ZONE WAS AT LEFT CAROTID ARTERY AS INTENDED, EXCLUSION OF THE LESION AND NO ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2189904 | 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 | 78 YR | Male | Hospitalization |