BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 20917057 · Received December 12, 2024

    Report

    Report Number
    2017233-2024-05587
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 12, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    UDI-DI
    00733132623822
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. H6 - CODE B14: REVIEW OF DEVICE MANUFACTURING RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS. H6 - CODE B01: THE ENGINEERING EVALUATION REPORT DETAILS OBSERVATIONS MADE DIRECTLY ON THE RETURNED DEVICE IN ADDITION TO DEVICE PHOTOS CAPTURED DURING EVALUATION. THOUGH NEITHER THE TIMING NOR ROOT CAUSE OF THE PARTIAL EXPANSION OF THE ENDOPROSTHESIS COULD BE DETERMINED WITH THE AVAILABLE INFORMATION, THE OBSERVATION OF A PARTIALLY EXPANDED ENDOPROSTHESIS AS RETURNED IS CONSISTENT WITH COMPLAINT OF ENDOPROSTHESIS EXPANSION. THE ROOT CAUSE OF THE REPORTED PREMATURE ENDO EXPANSION COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. THE ROOT CAUSE OF THE OTHER OBSERVED DAMAGE IS CONSISTENT WITH DEVICE MANIPULATION DURING PROCEDURE AS REPORTED. PER IFU FOR GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WARNINGS SECTION STARE: DO NOT WITHDRAW THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE BACK INTO THE INTRODUCER SHEATH ONCE THE ENDOPROSTHESIS IS FULLY INTRODUCED. WITHDRAWING THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE BACK INTO THE SHEATH CAN CAUSE DAMAGE TO THE ENDOPROSTHESIS, PREMATURE DEPLOYMENT, DEPLOYMENT FAILURE, AND/OR CATHETER SEPARATION. IF REMOVAL PRIOR TO DEPLOYMENT IS NECESSARY, WITHDRAW THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE TO A POSITION CLOSE TO BUT NOT INTO THE INTRODUCER SHEATH. BOTH THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE AND INTRODUCER SHEATH CAN THEN BE REMOVED IN TANDEM. AFTER REMOVAL, DO NOT REUSE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE OR INTRODUCER SHEATH. 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

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, PATIENT PRESENTED FOR TREATMENT OF AN ANEURYSMAL LEFT HYPOGASTRIC ARTERY. ACCESS WAS FROM THE RIGHT GROIN. AS REPORTED, THE PHYSICIAN USED COILS FOR A PORTION OF THE ANEURYSM, THEN DEPLOYED A 6 X 5 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) IN THE DISTAL HYPOGASTRIC ARTERY. A 7FR TOURGUIDE STEERABLE SHEATH WAS USED TO ADVANCE AN 8 X 10 VSX DEVICE OVER A .035 MEIER WIRE FOR IMPLANT WITHIN THE HYPOGASTRIC ARTERY. AS REPORTED, THE VSX DEVICE WAS PULLED BACK THROUGH THE SHEATH AND ONTO THE BACK TABLE SO THE SHEATH CAN BE READJUSTED. AFTER THE SHEATH WAS MANIPULATED, THE SAME VSX DEVICE WAS ADVANCED AGAIN INTO THE HYPOGASTRIC ARTERY. AS THE VSX DEVICE WAS ADVANCED BEYOND THE SHEATH, THE DEVICE STARTED EXPANDING UNEXPECTEDLY. IT WAS REPORTED THE DEPLOYMENT KNOB WAS NOT UNSCREWED. ATTEMPTS WERE MADE TO PULL THE EXPANDING DEVICE BACK INTO THE SHEATH, BUT THIS WAS NOT SUCCESSFUL. ABOUT HALF OF THE DEVICE REMAINED OUTSIDE THE SHEATH. CONSEQUENTLY, THE SHEATH, DEVICE AND GUIDEWIRE WERE PULLED OUT TOGETHER. THIS RESULTED IN DAMAGE TO THE COMMON FEMORAL ARTERY ACCESS SITE. THE PHYSICIAN DID A CUTDOWN AND AN OPEN REPAIR WAS DONE. USING THE SAME ACCESS SITE, A NEW 8 X 10 VSX DEVICE WAS ADVANCED AND DEPLOYED WITH GOOD OUTCOME. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858740 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC. 00733132623822

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention