GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
Report
- Report Number
- 3007284313-2023-02288
- Event Type
- Malfunction
- Date Received
- January 3, 2023
- Date of Event
- December 6, 2022
- Report Date
- March 3, 2023
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- UDI-DI
- 00733132651061
- PMA / PMN Number
- P200030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION FINDINGS - CODE C19: IMAGES WERE PROVIDED AND AN IMAGING EVALUATION WAS PERFORMED. THE IMAGING EVALUATION SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: PRE-IMPLANTATION CTA DATED (B)(6) 2022. OBLIQUE 3D IMAGES SHOW TORTUOSITY IN THE PROXIMAL AND MID-DISTAL LCI. THERE IS CALCIUM WITHIN THE LCI. H.6. INVESTIGATION CONCLUSIONS CODE D16 REMAINS UNCHANGED H.6. INVESTIGATION FINDINGS: CODE C21 UPDATED TO CODE C19.
H.6. INVESTIGATION FINDINGS: CODE C19 - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOTS INVOLVED IN THIS EVENT MET ALL PRE-RELEASE SPECIFICATIONS. H.6. INVESTIGATION FINDINGS: CODE C19 - THE DEVICE EVALUATION PERFORMED BY ENGINEERING SHOWED THE FOLLOWING: THE CATHETER WAS BROKEN NEAR THE TRANSITION BOND. THE BROKEN LEADING END OF THE CATHETER APPEARED STRETCHED AND MEASURED APPROXIMATELY 15.1 CM FROM THE BREAK TO THE TRAILING END OF THE LEADING TIP. DAMAGE TO THE BACK OF THE LEADING TIP WAS NOTED. THESE OBSERVATIONS ARE CONSISTENT WITH THE LEADING TIP BEING CAUGHT AND BEING PULLED WITH FORCE. THE INNER MEMBER OF THE CATHETER WAS BROKEN, BUT THE TRANSITION BOND WAS INTACT. BASED ON THE FINDINGS FROM THE EVALUATION, THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE PHYSICIAN¿S OBSERVATIONS THAT, ¿AS THE DELIVERY CATHETER WAS BEING REMOVED, RESISTANCE WAS FELT,¿ AND, ¿THE LEADING OLIVE TIP BROKE OFF OF THE CATHETER ALONG THE POLYIMIDE WIRE¿. HOWEVER, NO MANUFACTURING DEFECT WAS IDENTIFIED. THE ROOT CAUSE OF THE LEADING TIP OF THE CATHETER BREAKING FROM THE DEVICE COULD NOT BE DETERMINED WITH THE CURRENT INFORMATION AND THEREFORE THE PHYSICIAN¿S STATEMENT THAT, "THE RESISTANCE WAS ATTRIBUTED TO THE TORTUOSITY,¿ COULD NOT BE CONFIRMED. H.6. INVESTIGATION CONCLUSIONS CODE D1101 ADDED. THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) INSTRUCTS USERS TO NOT CONTINUE TO WITHDRAW THE DELIVERY CATHETER IF RESISTANCE IS FELT DURING REMOVAL THROUGH THE INTRODUCER SHEATH. FORCIBLY WITHDRAWING THE DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH WHEN RESISTANCE IS ENCOUNTERED HAS RESULTED IN ADVERSE EVENTS INCLUDING CATHETER SEPARATION AND REINTERVENTION. ADDITIONALLY, USERS ARE INSTRUCTED TO USE FLUOROSCOPIC GUIDANCE DURING THE WITHDRAWAL OF THE DELIVERY CATHETER TO ASSURE SAFE REMOVAL FROM THE ENDOPROSTHESIS. IF RESISTANCE IS FELT DURING REMOVAL OF DELIVERY CATHETER THROUGH THE INTRODUCER SHEATH, STOP AND WITHDRAW DELIVERY CATHETER AND INTRODUCER SHEATH TOGETHER. H.6. INVESTIGATION FINDINGS FOR PRODUCTION RECORDS: CODE C21 UPDATED TO CODE C19. H.6. INVESTIGATION FINDINGS FOR TESTING OF ACTUAL/SUSPECTED DEVICE: CODE C21 UPDATED TO CODE C19. H.6. INVESTIGATION CONCLUSIONS CODE D16 UPDATED TO CODE D1001.
(B)(4). 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) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. AS THE DELIVERY CATHETER WAS BEING REMOVED, RESISTANCE WAS FELT. IT WAS NOTED THAT THE PATIENT'S PROXIMAL LEFT COMMON ILIAC ARTERY WAS TORTUOUS AND THE RESISTANCE WAS ATTRIBUTED TO THE TORTUOSITY. THE PHYSICIAN CONTINUED PULLING THE DELIVERY CATHETER IN AN ATTEMPT TO REMOVE IT, AND THE LEADING OLIVE TIP BROKE OFF OF THE CATHETER ALONG THE POLYIMIDE WIRE. THE REMAINING DELIVERY CATHETER WAS REMOVED AND THE BROKEN LEADING END WAS SUCCESSFULLY SNARED. IT WAS NOTED THAT A STIFF GUIDEWIRE WAS USED DURING THE PROCEDURE AND THAT THE CATHETER BREAK WAS ATTRIBUTED SOLELY TO THE TORTUOSITY NOTED IN THE PATIENT'S ARTERY. THERE WERE NO PIECES LEFT IN THE PATIENT AND NO FURTHER REPORTED ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652601 | GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | CXT321414 | 00733132651061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male |