BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 15992384 · Received December 15, 2022

    Report

    Report Number
    2017233-2022-03579
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    September 28, 2022
    Report Date
    December 28, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. TITLE: TREATMENT RESULTS OF VIABAHN STENT GRAFTS IN PATIENTS WITH FREQUENT STENOSIS WITH ARTIFICIAL ENDOVASCULAR SHUNTS SOURCE: KIDNEY AND DIALYSIS 2022: 93(SUPPLEMENT ACCESS2022) P.276-278. 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.

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, IT WAS DETERMINED THIS IS NOT A REPORTABLE COMPLAINT. THEREFORE, MANUFACTURER REPORT # 2017233-2022-03579 IS BEING RETRACTED. THERE IS NO ALLEGATION OF DEVICE DEFICIENCY OR MALFUNCTION, AND THE AUTHOR DID NOT PROVIDE ANY REQUESTED DETAILS.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLISHMENT WAS REVIEWED BY GORE: TITLE: TREATMENT RESULTS OF VIABAHN STENT GRAFTS IN PATIENTS WITH FREQUENT STENOSIS WITH ARTIFICIAL ENDOVASCULAR SHUNTS. SOURCE: KIDNEY AND DIALYSIS 2022: 93(SUPPLEMENT ACCESS2022) P.276-278. THIS IS A REPORT OF THE TREATMENT PROGRESS AT 6 MONTHS IN 9 CASES IN WHICH GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. WAS USED FOR VENOUS ANASTOMOTIC STENOSIS OF AN ARTIFICIAL ENDOVASCULAR SHUNT AT OUR HOSPITAL FROM AUGUST 2020 TO DECEMBER 2020. EIGHT OF THE NINE CASES HAD FREQUENT STENOSIS REQUIRING PTA MORE THAN TWICE WITHIN THE LAST THREE MONTHS. IN 8 CASES WITH FREQUENT STENOSIS, THE AVERAGE NUMBER OF INTERVENTIONS DECREASED FROM 3.5 TIMES TO 0.5 TIMES 6 MONTHS BEFORE AND AFTER VIABAHN PLACEMENT. THREE CASES REQUIRED INTERVENTION, ALL OF THEM UNDERWENT SURGICAL THROMBECTOMY FOR THROMBUS OCCLUSION. SIX MONTHS LATER, THE PRIMARY PATENCY RATE WAS 66.7% AND THE SECONDARY PATENCY RATE WAS 100%. IN 2 OF THE 3 CASES REQUIRING INTERVENTION, ANGIOGRAPHY AT THE TIME OF OCCLUSION REVEALED STENOSIS AT THE PROXIMAL END OF THE VIABAHN. RETROSPECTIVELY, ANGIOGRAPHIC FINDINGS AT THE TIME OF VIABAHN PLACEMENT REVEALED THAT MILD NARROWING OF THE VENOUS LUMEN WAS OBSERVED AT THE PROXIMAL END OF VIABAHN IN ALL THREE CASES REQUIRING INTERVENTION. ON THE OTHER HAND, VENOUS NARROWING WAS NOT OBSERVED IN CASES REQUIRING NO INTERVENTION. VIABAHN IS EFFECTIVE IN THE TREATMENT OF STENOSIS AT THE ANASTOMOSIS OF ARTIFICIAL BLOOD VESSELS, AND FURTHER IMPROVEMENT OF TREATMENT RESULTS IS EXPECTED BY APPROPRIATELY SETTING THE IMPLANT RANGE.

    Description of Event or Problem · 0

    THE FOLLOWING PUBLICATION WAS REVIEWED: TREATMENT RESULTS OF VIABAHN STENT GRAFTS IN PATIENTS WITH FREQUENT STENOSIS WITH ARTIFICIAL ENDOVASCULAR SHUNTS. SOURCE KIDNEY AND DIALYSIS 2022: 93(SUPPLEMENT ACCESS2022) P.276-278. AUTHOR SOJI MORIWAKI, KAIKOUKAI. THE REPORT REFERS TO TREATMENT PROGRESS AT 6 MONTHS IN 9 CASES IN WHICH VIABAHN WAS USED FOR VENOUS ANASTOMOTIC STENOSIS OF AN ARTIFICIAL ENDOVASCULAR SHUNT AT OUR HOSPITAL FROM AUGUST 2020 TO DECEMBER 2020. PRIOR TO IMPLANT, EIGHT (8) OF THE NINE (9) CASES HAD FREQUENT STENOSIS REQUIRING PTA MORE THAN TWICE WITHIN THE LAST THREE MONTHS. IN THE EIGHT (8) CASES WITH FREQUENT STENOSIS, THE AVERAGE NUMBER OF INTERVENTIONS DECREASED FROM 3.5 TIMES TO 0.5 TIMES AT 6 MONTHS AFTER VIABAHN PLACEMENT. THREE (3) CASES REQUIRED INTERVENTION, AND ALL UNDERWENT SURGICAL THROMBECTOMY FOR THROMBUS OCCLUSION. IN TWO (2) OF THE THREE (3) CASES REQUIRING INTERVENTION, ANGIOGRAPHY AT THE TIME OF OCCLUSION REVEALED STENOSIS AT THE PROXIMAL END OF THE VIABAHN DEVICES. AT SIX (6) MONTHS, THE PRIMARY PATENCY RATE WAS 66.7% AND THE SECONDARY PATENCY RATE WAS 100%. FOR THE THREE CASES REQUIRING INTERVENTION, THE RETROSPECTIVE, ANGIOGRAPHIC FINDINGS AT THE TIME OF VIABAHN PLACEMENT REVEALED MILD NARROWING OF THE VENOUS LUMEN AT THE PROXIMAL END OF VIABAHN DEVICES. ON THE OTHER HAND, VENOUS NARROWING WAS NOT OBSERVED IN CASES REQUIRING NO INTERVENTION. VIABAHN IS EFFECTIVE IN THE TREATMENT OF STENOSIS AT THE ANASTOMOSIS OF ARTIFICIAL BLOOD VESSELS, AND FURTHER IMPROVEMENT OF TREATMENT RESULTS IS EXPECTED BY APPROPRIATELY SETTING THE IMPLANT RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2777228 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O