BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 20951594 · Received December 17, 2024

    Report

    Report Number
    2017233-2024-05618
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 20, 2024
    Report Date
    February 24, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. THE VIABAHN® DEVICE WAS RETURNED TO GORE FOR EVALUATION. THE OUTER ZIPPER WAS FULLY DEPLOYED TO THE TURNAROUND OUT. THE INNER ZIPPER WAS PARTIALLY DEPLOYED HALFWAY THROUGH THE FIRST DISTAL STENT ROW. THERE WAS NO EXPANSION OF THE ENDOPROSTHESIS. THE EVALUATION HAS OBSERVED THE DEPLOYMENT MECHANISM TO BE FUNCTIONAL: THE DEPLOYMENT LINE WAS NOT CAUGHT ON ANY PART OF THE DEVICE AND DEPLOYMENT CONTINUED DURING EVALUATION. THE CAUSE FOR THE REPORTED DEPLOYMENT DIFFICULTY COULD NOT BE ESTABLISHED. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE MET PRE-RELEASE SPECIFICATIONS. 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 INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN AN UNKNOWN ANATOMICAL LOCATION DURING TREATMENT OF AN UNKNOWN ETIOLOGY. AFTER THE VSX DEVICE WAS ADVANCED ACROSS THE LESION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. HOWEVER, THE DEPLOYMENT LINE WAS PULLED AND REMOVED WITH NO DEVICE EXPANSION. AN ANGIOGRAM CONFIRMED NO DEVICE EXPANSION AND THE VSX DEVICE WAS REMOVED THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN). THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486159 GORE® VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown