BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® VIABAHN® ENDOPROSTHESIS

    MDR report key: 6975513 · Received October 25, 2017

    Report

    Report Number
    2017233-2017-00552
    Event Type
    Malfunction
    Date Received
    October 25, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 26, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ENGINEERING EVALUATION SHOWED THE FOLLOWING: THE DEVICE WAS RETURNED WITH NO ENDOPROSTHESIS AND TWO SEPARATE SECTIONS OF DEPLOYMENT LINE. ONE SECTION OF DEPLOYMENT LINE, WHICH WAS CONNECTED TO THE KNOB, MEASURED 149.5CM. THERE WERE THREE SINGLE FIBERS EXTENDING PAST THE END OF THIS SECTION OF LINE, MEASURING 0.5CM, 7CM, AND 12.2CM. THE SECOND SECTION OF DEPLOYMENT LINE MEASURED 22CM. THIS PORTION CONTAINED A 12CM SINGLE FIBER LOOP. THERE WERE TWO SINGLE FIBERS EXTENDING PAST THE END OF THIS SECTION OF LINE, MEASURING 4.5CM AND 56CM. THE DELIVERY CATHETER APPEARS UNREMARKABLE. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. UDI: ((B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO REPAIR OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY USING GORE® VIABAHN® ENDOPROSTHESES. TOTAL LENGTH OF THE LESION WAS APPROXIMATELY 17 CM WHICH INCLUDED STENOSIS 7 CM (PROXIMAL) AND CHRONIC TOTAL OCCLUSION (CTO) 10 CM (DISTAL). IPSILATERAL ANTEGRADE APPROACH WAS APPLIED, AND 6 FR PARENT SHEATH WAS INSERTED. GUIDEWIRE WAS JUPITER FC (3G). ARMET MICROCATHETER PASSED THROUGH THE CTO LESION WITHOUT DIFFICULTY. THERE WAS CALCIFICATION, AND CROSSER RECANALIZATION CATHETER WAS USED WITH CHEVALIER UNIVERSAL 300 CM AGAINST THE CALCIFICATION. AFTER THAT, PRE-BALLOONING WAS PERFORMED USING SHIDEN-HP BALLOON CATHETER (5 MM X 4 CM) WITH 20 ATM. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, AND THE GUIDEWIRE WAS EXCHANGED TO AGURU SUPPORT 300 CM AT THAT TIME. IT WAS ELECTED TO USE 5 MM GORE® VIABAHN® ENDOPROSTHESES FOR THE CASE. THE PHYSICIAN ELECTED TO IMPLANT THE FIRST ENDOPROSTHESIS FROM THE DISTAL PORTION OF THE LESION. THE DELIVERY CATHETER WAS ADVANCED TO THE INTENDED POSITION, AND THE DEPLOYMENT LINE WAS PULLED. HOWEVER, THE ENDOPROSTHESIS WAS PARTIALLY DEPLOYED AND PROXIMAL PORTION (AROUND 3 CM IN THE LENGTH) WAS NOT OPENED. THE CATHETER WAS PULLED WITH FORCE, AND THE ENDOPROSTHESIS WAS TOTALLY DEPLOYED, AND IT BECAME POSSIBLE TO WITHDREW THE DELIVERY CATHETER. IT WAS SUSPECTED THAT THE LINE WAS BROKEN. IVUS COULD NOT CONFIRM A DETACHED LINE IN THE PATIENT, HOWEVER, WHEN IVUS WAS WITHDRAWN, THE LINE WAS ALSO WITHDRAWN FROM A SHEATH. THE PHYSICIAN WONDERED IF MORE PORTION OF THE LINE REMAINED IN THE PATIENT, AND THE GUIDEWIRE AND THE SHEATH WERE PULLED DOWN A LITTLE. ANOTHER DETACHED LINE WAS THEN OBSERVED WITH THE GUIDEWIRE, SO THE LINE WAS REMOVED FROM THE PATIENT. SECOND ENDOPROSTHESIS WAS DEPLOYED PROXIMAL TO THE FIRST ENDOPROSTHESIS AS PLANNED. POST-BALLOONING WAS PERFORMED USING SHIDEN-HP BALLOON CATHETER (5 MM X 4 CM) WITH 20 ATM. IVUS AND FINAL ANGIOGRAPHY SHOWED NO ISSUE, AND THE PROCEDURE WAS CONCLUDED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754923 GORE® VIABAHN® ENDOPROSTHESIS NIP PFV W.L. GORE & ASSOCIATES 16525530

    Patients

    Seq Age Sex Outcome Treatment
    1