BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 10085255 · Received May 25, 2020

    Report

    Report Number
    2017233-2020-00387
    Event Type
    Malfunction
    Date Received
    May 25, 2020
    Date of Event
    May 7, 2020
    Report Date
    August 5, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIO
    PMA / PMN Number
    P160021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION C1: NAME: CBAS® HEPARIN SURFACE, MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC., LOT NUMBER: 21848925, ADDITIONAL MANUFACTURER NARRATIVE: CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H.6. RESULTS CODE 2: 213: THE ENGINEERING EVALUATION STATED THE FOLLOWING: THE DEVICE WAS IDENTIFIED TO BE AN 11 X 79 X 1350 MM CONFIGURATION, WHICH MATCHES THE EVENT DESCRIPTION . THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS SENT BACK DEPLOYED. THE CATHETER HUB WAS SENT BACK SEPARATED FROM THE REST OF THE DELIVERY SYSTEM. CATHETER MATERIAL WAS PRESENT IN THE CATHETER HUB INDICATING A CATHETER TENSILE FAILURE RATHER THAN A BOND FAILURE. CATHETER DAMAGE WAS OBSERVED AT 0 - 0.5 CM, 5.5 ¿ 8.5 CM, AND 14.5, 15 CM FROM THE POINT OF SEPARATION. THE DEVICE HISTORY FILE WAS REVIEWED AND NO ANOMALIES WERE IDENTIFIED. SAMPLES OF THE DELIVERY CATHETER LOT MET SPECIFICATIONS FOR TENSILE STRENGTH. THE CATHETER OF THE VBX DELIVERY SYSTEM IS 100% INSPECTED AT THE END OF THE MANUFACTURING PROCESS FOR ANY VISUAL DAMAGE. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED TO WHICH THE EVENT COULD BE DEFINITIVELY ATTRIBUTED.

    Additional Manufacturer Narrative · 0

    H.6. RESULTS CODE 1: 213: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    H.1. UPDATED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT TREATMENT OF AN INTERNAL ILIAC ANEURYSM WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS UTILIZED FOR THE INTERNAL ILIAC ARTERY COMPONENT. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ADVANCED OVER AN AMPLATZ WIRE THROUGH AN 8FR 90CM DESTINATION SHEATH IN THE AXILLARY ARTERY. THE DEVICE WAS TIGHT IN THIS SHEATH HOWEVER IT TRACKED INTO POSITION AND DEPLOYED SUCCESSFULLY. AS THE BALLOON CATHETER WAS BEING REMOVED IT WAS TIGHT IN THE SHEATH AND THE HUB PORTION BROKE AWAY FROM THE DELIVERY CATHETER. THE WIRE AND DELIVERY CATHETER WERE THEN REMOVED TOGETHER SUCCESSFULLY. THE PATIENT OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548999 GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS STENT, ILIAC NIO W.L. GORE & ASSOCIATES 21848925

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR