BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9936962 · Received April 8, 2020

    Report

    Report Number
    2017233-2020-00237
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 12, 2020
    Report Date
    April 15, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P130006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CODE 4112: DICOM IMAGING SERIES WERE REQUESTED BUT NOT PROVIDED TO GORE. INSTEAD INTRAOPERATIVE ANGIOGRAPHIC JPEG IMAGES AND ONE VIDEO OF A PRE-TREATMENT COMPUTED TOMOGRAPHY WERE PROVIDED FOR EVALUATION. CODE 213: THE IMAGING EVALUATION STATES THE FOLLOWING: IMAGING PROVIDED FOR REVIEW FOR THIS EVENT ARE INTRAOPERATIVE ANGIOGRAPHIC JPEG IMAGES AND ONE (1) VIDEO OF A PRETREATMENT CT. PRE CT VIDEO ILLUSTRATES THAT THE RIGHT SFA APPEARS TO BE OCCLUDED. INTRAOPERATIVE ANGIOGRAPHIC JPEG IMAGE ILLUSTRATES OCCLUSIVE DISEASE OF THE RIGHT SFA. A DISTORTED INTRAOPERATIVE ANGIOGRAPHIC JPEG IMAGE ILLUSTRATES WHAT APPEARS TO BE A PARTIALLY DEPLOYED STENT GRAFT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE SPECIFICATIONS. THE ENTIRE DEVICE WAS RETURNED FOR INVESTIGATION INCLUDING A SHEATH. THE SHEATH WAS NOT EVALUATED AS IT IS NOT A GORE PRODUCT. THE DEPLOYMENT LINE APPEARED TO BE BROKEN. THE SECTION STILL ATTACHED TO THE DEPLOYMENT KNOB MEASURED 182 CM, INCLUDING THREE SINGLE FIBERS MEASURING APPROXIMATELY 12 CM, 6.5 CM AND 0.3 CM. APPROXIMATELY 3.2 CM OF DEPLOYMENT LINE WAS STILL ATTACHED TO THE ENDOPROSTHESIS. APPROXIMATELY 5.5 CM OF THE ENDOPROSTHESIS WAS EXPANDED. THE REMAINDER OF THE ENDOPROSTHESIS WAS CONSTRAINED BY THE INNER BRAIDED CONSTRAINING LINE. DEPLOYMENT WAS ABLE TO BE CONTINUED WITH TRACTION ON THE DEPLOYMENT LINE AT THE ENDOPROSTHESIS. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED TO WHICH THE EVENT COULD BE DEFINITIVELY ATTRIBUTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT ENDOVASCULAR RECANALIZATION OF THE SUPERFICIAL FEMORAL ARTERY UNDER GENERAL ANESTHESIA. IT WAS PLANNED TO TREAT THE LESION WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE. AFTER THE PHYSICIAN PRE-DILATED THE LESION TO 5FR, THEY EASILY PLACED THE VIABAHN® ENDOPROSTHESIS IN THE INTENDED POSITION THROUGH A 7FR INTRODUCER SHEATH OVER A 260 CM LONG STIFF GUIDE WIRE. IT WAS REPORTED THAT THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHEN ADVANCING THE VIABAHN® ENDOPROSTHESIS. AFTER THE VIABAHN® ENDOPROSTHESIS WAS CORRECTLY POSITIONED THE PHYSICIAN TURNED THE DEPLOYMENT KNOB TO INITIATE DEPLOYMENT OF THE VIABAHN® ENDOPROSTHESIS, PULLED THE WHITE DEPLOYMENT LINE AND OBSERVED THE DEPLOYMENT OF THE VIABAHN® ENDOPROSTHESIS BY FLUOROSCOPIC IMAGING. AFTER THE DEPLOYMENT LINE WAS COMPLETELY EXTRACTED FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE VIABAHN® ENDOPROSTHESIS HAD NOT FULLY DEPLOYED. PART OF THE VIABAHN® ENDOPROSTHESIS REMAINED CONSTRAINED. TO RELEASE THE VIABAHN® ENDOPROSTHESIS FROM THE DELIVERY CATHETER, THE PHYSICIAN MOVED THE DELIVERY CATHETER AND TRIED TO WITHDRAW IT, BUT THE VIABAHN® ENDOPROSTHESIS DID NOT RELEASE FROM THE DELIVERY CATHETER. IT WAS REPORTED THAT THE PHYSICIAN THEN TRIED TO RETRACT THE PARTIALLY DEPLOYED VIABAHN® ENDOPROSTHESIS BACK INTO THE INTRODUCER SHEATH. BUT THIS DID NOT WORK. THEREFORE THE PHYSICIAN DECIDED TO CONVERT TO OPEN SURGERY TO REMOVE THE VIABAHN® ENDOPROSTHESIS FROM THE PATIENT. TO COMPLETE THE PROCEDURE, THE PHYSICIAN THEN USED A BARE METAL STENT (BARD) TO TREAT THE LESION. IT WAS MENTIONED THAT THE PROCEDURE TOOK TWO HOURS LONGER THAN PLANNED. IT WAS STATED THAT THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402634 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES 21451523

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization