BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 6939049 · Received October 10, 2017

    Report

    Report Number
    2017233-2017-00532
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 14, 2017
    Report Date
    October 18, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P130006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE - CORRECTION OF SECTION ¿2. COMMON DEVICE NAME¿ FROM PFV / NIP TO NIP / STENT, SUPERFICIAL FEMORAL ARTERY. ENGINEERING EVALUATION: THE GORE® VIABAHN® ENDOPROSTHESIS WAS RETURNED WITH NO ENDOPROSTHESIS AND A SINGLE SECTION OF DEPLOYMENT LINE ATTACHED TO THE KNOB. THERE WAS A KNOT IN THE DEPLOYMENT LINE 49CM FROM THE KNOB, WHICH CREATED A LOOP CONSISTING OF 67CM OF DEPLOYMENT LINE AND A SINGLE FIBER EXTENDING AN ADDITIONAL 32CM BACK TO THE KNOT. AT THE KNOT, THERE WAS A 9CM SINGLE FIBER LOOP. AT THE KNOT, THERE WAS A 25CM SINGLE FIBER. THE DELIVERY CATHETER APPEARS UNREMARKABLE. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH AN IN-STENT RESTENOSIS WITHIN THE LEFT POPLITEAL ARTERY, SEGMENT II, WHICH WAS INTENDED TO BE TREATED WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE MEDICAL DEVICE WAS INSERTED THROUGH A 6FR TERUMO INTRODUCER SHEATH AND ADVANCED OVER A 0.018 GUIDEWIRE TO THE TARGET LESION. IT WAS REPORTED TO GORE THAT WHEN DEVICE DEPLOYMENT WAS INITIATED, NO DIFFICULTIES WERE EXPERIENCED OR ABNORMALITIES NOTED. IT WAS STATED THAT WHEN THE DEPLOYMENT LINE OF THE GORE® VIABAHN® ENDOPROSTHESIS WAS PULLED BACK A VISUAL INSPECTION INDICATED A DEPLOYMENT LINE BREAKAGE. CONSEQUENTLY AN ANGIOGRAPHY WAS PERFORMED WHICH INDICATED THAT THE GORE® VIABAHN® ENDOPROSTHESIS WAS PARTIALLY DEPLOYED. AS FURTHER DEVICE DEPLOYMENT COULD NOT BE INITIATED, BASED ON THE BROKEN DEPLOYMENT LINE, AN ATTEMPT WAS MADE TO REMOVE THE PARTIAL DEPLOYED ENDOPROSTHESIS THROUGH THE INTRODUCER SHEATH. AS THIS EFFORT WAS NOT SUCCESSFUL, THE GORE® VIABAHN® ENDOPROSTHESIS WAS MOVED BACK TO THE TARGET LESION. IT WAS STATED THAT A BALLOON WAS INSERTED NEXT TO THE DEPLOYED PORTION OF THE ENDOPROSTHESIS WITH THE IDEA TO HAVE THE DEVICE FIXATED ON THE VESSEL WALL WHILE THE CATHETER WAS REMOVED WITH FORCE FROM THE ENDOPROSTHESIS. DURING THIS MANEUVER THE CONSTRAINED PORTION OF THE GORE® VIABAHN® ENDOPROSTHESIS DEPLOYED SUCCESSFULLY. AS A NEW ACCESS TO A SMALLER VESSEL WAS GAINED DURING THIS PROCEDURE IT WAS DECIDED TO IMPLANT ANOTHER BARE METAL STENT INTO THE PATIENT¿S VESSEL WITH THE CONSEQUENCE THAT THE STENT CRUSHED THE GORE® VIABAHN® ENDOPROSTHESIS TO THE VESSELS WALL. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713233 GORE® VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 16160061

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR