BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9979558 · Received April 20, 2020

    Report

    Report Number
    2017233-2020-00259
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    April 3, 2020
    Report Date
    July 29, 2020
    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 · 0

    THE ENGINEERING EVALUATION IS AS FOLLOWS: THE DEPLOYMENT LINE, DEPLOYMENT KNOB, AND DELIVERY CATHETER WERE RETURNED. A CAP WAS ATTACHED TO THE DEPLOYMENT LINE PORT; HOWEVER, IT WAS NOT EVALUATED AS IT IS NOT A GORE PRODUCT. THERE WAS APPROXIMATELY 162 CM OF DEPLOYMENT LINE ATTACHED TO THE DEPLOYMENT KNOB, INCLUDING A SINGLE FIBER MEASURING APPROXIMATELY 1.8 CM. THE REMAINDER OF THE DEVICE WAS UNREMARKABLE. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED TO WHICH THE EVENT COULD BE DEFINITIVELY ATTRIBUTED. ENGINEERING EVALUATION CONCLUSION IS INCONCLUSIVE AS IT RELATES TO THE EVENT DESCRIPTION. RESULTS CODE 2 - UPDATED TO 213. CONCLUSION CODE - UPDATED TO 4315.

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURING NARRATIVE: C1. NAME (#1) - CBAS® HEPARIN SURFACE; MANUFACTURER/COMPOUNDER: W. L. GORE & ASSOCIATES, INC. LOT #20343959. CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE EVALUATION IS ONGOING.

    Description of Event or Problem · 1

    THE FOLLOWING IS REPORTED TO GORE: ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN) FOR CHRONIC TOTAL OCCLUSION IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE DELIVERY CATHETER WAS ADVANCED FROM THE CONTRALATERAL SIDE TO THE TARGET LOCATION. REPORTEDLY, WHEN THE PHYSICIAN STARTED TO PULL THE DEPLOYMENT LINE, HE FELT RESISTANCE. AFTER THAT NO PARTICULAR ISSUE WAS NOTED. AFTER APPROXIMATELY ONE THIRD OF THE DEVICE WAS DEPLOYED, THE DEPLOYMENT LINE BROKE. THE SHEATH WAS ADVANCED TO THE DEVICE, AND THE DELIVERY CATHETER WAS PULLED BACK INTO THE SHEATH, AT THIS POINT THE STENT GRAFT WAS DEPLOYED ABOUT TWO THIRDS. HOWEVER, DURING THIS APPROACH, THE STENT GRAFT MOVED ABOUT 15 CM IN THE PROXIMAL DIRECTION AND THE PHYSICIAN STOPPED PULLING THE CATHETER FURTHER INTO THE SHEATH. A 6 MM BALLOON (MANUFACTURER UNKNOWN) WAS ADVANCED RETROGRADE TO THE DEVICE, AND THE UNDEPLOYED PORTION OF THE STENT GRAFT WAS EXPANDED. AN ADDITIONAL VIABAHN AND A STENT (ELUVIA) WERE DEPLOYED TO EXTEND THE DEVICE AND COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE DEPLOYMENT LINE MIGHT HAVE BEEN CAUGHT WHEN THE PHYSICIAN STARTED TO PULLING. NO CALCIFICATION WAS OBSERVED IN THE LESION. THE CAUSE OF THE DEPLOYMENT LINE BROKE WAS NOT IDENTIFIED. THE REPORTED DEVICE IS RETURNED TO GORE FOR ANALYSIS. A PHYSICIAN LETTER IS REQUESTED. HE ALSO REQUESTED TO KNOW WHETHER THE DELIVERY CATHETER HAD ANY DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439972 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES 20343959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other