BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 19035724 · Received April 3, 2024

    Report

    Report Number
    2017233-2024-04786
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 11, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    UDI-DI
    00733132623815
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. 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

    D4: CATALOG NUMBER: VBJR080502A; SERIAL NUMBER: (B)(6); EXPIRATION DATE, 29-NOV-2026; UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    SECTION H6 UPDATED TO REFLECT COMPLETION OF INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE DEVICE LOTS MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. THE CAUSE FOR THE REPORTED INABILITY TO DEPLOY THE DEVICE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION. THE INVESTIGATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE CAUSE OF THE REPORTED EVENT BASED ON EVALUATION OF THE RETURNED DELIVERY SYSTEM AND THE INFORMATION REPORTED TO GORE. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON MARCH 22, 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE ARM DURING TREATMENT OF A CLOTTED GRAFT (ARTEGRAFT® COLLAGEN VASCULAR GRAFT). AFTER THE DEVICE WAS ADVANCED THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) OVER A 0.018" PLATINUM PLUS GUIDE WIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, THE ZIPPER BOUND AT THE TURN AROUND AND WAS UNABLE ACHIEVE ANY DEVICE EXPANSION. AFTER A FEW ATTEMPTS AND NO DEVICE EXPANSION THE PHYSICIAN REMOVED THE VSX DEVICE THROUGH THE INTRODUCER SHEATH. AN ADDITIONAL VSX DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1784454 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC. 00733132623815

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male