GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
Report
- Report Number
- 2017233-2023-04489
- Event Type
- Injury
- Date Received
- December 19, 2023
- Date of Event
- November 14, 2023
- Report Date
- January 23, 2024
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- PFV
- PMA / PMN Number
- P130006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. SECTION D: PRODUCT CODE CORRECTION. SECTION G: PMA/510K UPDATED TO P130006.
B3: UPDATED EVENT DESCRIPTION. H6: UPDATED FOR FINAL CODING. - D12: THE GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE INSTRUCTIONS FOR USE (IFU), FOR THE APPROPRIATE REGION AND TIME-PERIOD, WAS REVIEWED WITH RESPECT TO THE COMPLAINT DETAIL, AND THERE ARE APPLICABLE STATEMENTS. THE IFU STATES THE FOLLOWING: "POSSIBLE ADVERSE EVENTS AND COMPLICATIONS THAT MAY OCCUR WITH THE USE OF THIS DEVICE OR IN ANY ENDOVASCULAR PROCEDURE AND REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO OCCLUSION (THROMBOSIS AND/OR STENOSIS) OF ENDOPROSTHESIS OR VESSEL".
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.
THE FOLLOWING WAS REPORTED TO GORE FROM THE VIEDOC STUDY DATABASE: ON (B)(6) 2023, THIS 70-YEAR-OLD PATIENT UNDERWENT A SURGICAL TREATMENT FOR THE TREATMENT OF A GETINGE GRAFT THAT HAD BECOME OCCLUDED. THE TREATMENT INCLUDED THE CREATION OF AV GRAFT (NON-GORE) IN THE LEFT UPPER ARM WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) FOR TREATMENT OF A DE-NOVO LESION. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED. THE VSX-DEVICE WAS SUCCESSFULLY IMPLANTED AND THE STUDY DEVICE WAS PATENT. POST-DILATION WAS PERFORMED IN THE STENT GRAFT AND THE VEIN. ADDITIONALLY PTA, EMBOLIZATION, AND THROMBOLYSIS AND COIL EMBOLIZATION OF VEIN BRANCHES NEAR THE ANASTOMOSIS WERE ALSO PERFORMED. ON (B)(6), 2023, THE PATIENT WAS NOTED TO HAVE INCREASED VENOUS PRESSURES AND PROXIMAL STENT STENOSIS. THIS RESULTED IN HOSPITALIZATION AND A REINTERVENTION. THE EVENT IS NOTED TO BE RELATED TO THE ACCESS CIRCUIT. ON (B)(6), 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION TO THE LEFT UPPER ARM FOR RESTENOSIS. THE REPEAT INTERVENTION WAS WITHIN THE VSX STUDY DEVICE, WHERE AN ADDITIONAL GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) HAS BEEN IMPLANTED. AN ANTICOAGULANT WAS USED IN THE PROCEDURE. AT THE END OF THE PROCEDURE THE VSX DEVICE WAS NOTED TO BE PATENT. THE PATIENT WAS NOTED TO RECOVER WITHOUT SEQUELAE ON (B)(6) 2023.
THE FOLLOWING WAS REPORTED TO GORE FROM THE VIEDOC STUDY DATABASE: ON (B)(6) 2023, THIS 70-YEAR-OLD PATIENT UNDERWENT A SURGICAL TREATMENT FOR THE TREATMENT OF A GETINGE GRAFT THAT HAD BECOME OCCLUDED. THE TREATMENT INCLUDED THE CREATION OF AV GRAFT IN THE LEFT UPPER ARM WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) FOR TREATMENT OF A DE-NOVO LESION. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED. THE VSX-DEVICE WAS SUCCESSFULLY IMPLANTED AND THE STUDY DEVICE WAS PATENT. POST-DILATION WAS PERFORMED IN THE STENT GRAFT AND THE VEIN. ADDITIONALLY PTA, EMBOLIZATION, AND THROMBOLYSIS AND COIL EMBOLIZATION OF VEIN BRANCHES NEAR THE ANASTOMOSIS WERE ALSO PERFORMED. ON NOVEMBER 14, 2023, THE PATIENT WAS NOTED TO HAVE INCREASED VENOUS PRESSURES AND PROXIMAL STENT STENOSIS. THIS RESULTED IN HOSPITALIZATION AND A REINTERVENTION. THE EVENT IS NOTED TO BE RELATED TO THE ACCESS CIRCUIT. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION TO THE LEFT UPPER ARM FOR RESTENOSIS. THE REPEAT INTERVENTION WAS WITHIN THE VSX STUDY DEVICE. AN ANTICOAGULANT WAS USED IN THE PROCEDURE. AT THE END OF THE PROCEDURE THE VSX DEVICE WAS NOTED TO BE PATENT. THE PATIENT WAS NOTED TO RECOVER WITHOUT SEQUELAE ON (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1042356 | GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE | STENT, SUPERFICIAL FEMORAL ARTERY | PFV | W. L. GORE & ASSOCIATES, INC. | |||
| 1459460 | GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE | STENT, SUPERFICIAL FEMORAL ARTERY | PFV | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male | Required Intervention |