BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    MDR report key: 16662068 · Received April 3, 2023

    Report

    Report Number
    2017233-2023-03839
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 6, 2023
    Report Date
    April 3, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE STUDY NUMBER WITH CODES FOR THE HOSPITAL AND PATIENT. C. SUSPECTS PRODUCTS NAME AND STRENGTH: CBAS® HEPARIN SURFACE. MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT NUMBER: 25923918. DEVICE EVALUATED BY MFR: AS THE DEVICE REMAINS IMPLANTED, NO FURTHER INVESTIGATION CAN BE PERFORMED. EVALUATION CODES INVESTIGATION FINDINGS C19 REFERS TO THE PRODUCT HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. THE PHYSICIAN STATED THAT THE PRIMARY RELATIONSHIP IS DISEASE-RELATED. HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. IN THE INSTRUCTION FOR USE FOR THE GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE THE FOLLOWING IS STATED: HAZARDS AND ADVERSE EVENTS PROCEDURE RELATED: AS WITH ALL PROCEDURES THAT UTILIZE TECHNIQUES FOR INTRODUCING A CATHETER INTO A VESSEL, COMPLICATIONS MAY BE EXPECTED. THESE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: THROMBOSIS, OCCLUSION. DEVICE RELATED: COMPLICATIONS AND ADVERSE EVENTS CAN OCCUR WHEN USING ANY ENDOVASCULAR DEVICE. THESE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: STENOSIS, THROMBOSIS OR OCCLUSION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT ON (B)(6) 2022, FOR A DIALYSIS ACCESS CIRCUIT IN THE LEFT FOREARM WITH A LOOP GORE PROSTHETIC GRAFT (NOT FURTHER SPECIFIED). ON (B)(6) 2023, A DE NOVO VENOUS STENOSIS OCCURRED AT THE VENOUS OUTFLOW OF THE SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFT AS VERIFIED BY IMAGING (MPDCASE: (B)(4). TO SOLVE THE ISSUE A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VSX-DEVICE) WAS IMPLANTED. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED AND PRE- AND POST-DILATION AT VENOUS ANASTOMOSIS ON TO LEFT BASILIC VEIN PERFORMED. THE VSX-DEVICE WAS SUCCESSFULLY IMPLANTED AND THE STUDY DEVICE WAS PATENT. THERE WERE NO ADDITIONAL PROCEDURES PERFORMED AT TREATMENT. ON (B)(6) 2023, A CLOTTED GRAFT (OCCLUSION) WAS DISCOVERED, WHICH REQUIRED TREATMENT INCLUDING ANTIPLATELET / ANTICOAGULANT MEDICATION ON THE ACCESS CIRCUIT. ON (B)(6) 2023, A SURGICAL REINTERVENTION IN THE LEFT FOREARM WITHIN THE STUDY DEVICE WAS PERFORMED. THE VSX DEVICE PATENCY WAS RESTORED / MAINTAINED AT THE END OF THE PROCEDURE AND THERE WERE NO PROCEDURAL COMPLICATIONS. THE PHYSICIAN STATED THAT THE PRIMARY RELATIONSHIP IS DISEASE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116857 GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention