BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

    MDR report key: 12211815 · Received July 22, 2021

    Report

    Report Number
    2017233-2021-02193
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 28, 2021
    Report Date
    March 1, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    UDI-DI
    00733132623815
    PMA / PMN Number
    P130006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS WERE REVIEWED AND THE DEVICE MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS RETURNED TO GORE WITHOUT THE DELIVERY SYSTEM. THE ENDOPROSTHESIS WAS RETURNED FULLY EXPANDED AND WAS OTHERWISE UNREMARKABLE. CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED BASED ON EVALUATION OF THE RETURNED DEVICE, HOWEVER, INFORMATION ORIGINALLY REPORTED BY THE PHYSICIAN INDICATES THIS EVENT IS POTENTIALLY RELATED TO THE PATIENTS TORTUOUS ANATOMY. FURTHER INFORMATION REGARDING THIS EVENT WAS REQUESTED BY GORE, BUT NO FURTHER INFORMATION HAS BEEN REPORTED, THEREFORE THIS INVESTIGATION IS CONSIDERED COMPLETE. PMA/510(K)NUMBER CORRECTED TO P130006

    Additional Manufacturer Narrative · 1

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT PRESENTED WITH STENOSIS IN AN AV FISTULA AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) DEVICE. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE GUIDEWIRE, CATHETER, AND BALLOON TO THE LESION DUE TO THE PATIENTS TORTUOUS ANATOMY. THE PHYSICIAN WAS ULTIMATELY ABLE TO ADVANCE THE DEVICE TO THE LESION, BUT WHEN HE ATTEMPTED TO DEPLOY THE VSX DEVICE, THE DISTAL END OF THE DEVICE WOULD NOT FULLY DEPLOY. THE PHYSICIAN COMPLETELY REMOVED THE DEVICE AND DELIVERY SYSTEM. THE PHYSICIAN REPORTED THAT HE WAS ABLE TO FULLY DEPLOY THE DEVICE ONCE IT WAS OUTSIDE OF THE PATIENT, SO HE SUSPECTS THE PARTIAL DEPLOYMENT WAS DUE TO TORTUOUS ANATOMY AND CALCIFICATION AND NOT A DEFECT WITH THE DEVICE. THE DEVICE WILL BE RETURNED. NO OTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106255 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE SYSTEM, ENDO GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC. VBJR080502A 00733132623815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown