BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 6079646 · Received November 4, 2016

    Report

    Report Number
    2017233-2016-00843
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    July 30, 2016
    Report Date
    November 7, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE RESULTS OF THE ENGINEERING EVALUATION, THE 5MM DEVICE WAS THE ONE THAT WAS PARTIALLY DEPLOYED AND EXPLANTED, NOT THE 6MM DEVICE. THE ENGINEERING EVALUATION STATED THAT THE FOLLOWING OBSERVATIONS WERE MADE: THERE WERE 2 CATHETERS PRESENT AND 1 DEPLOYED ENDOPROSTHESIS. THE ENDOPROSTHESIS PRESENT HAS 7 APICES, WHICH MEANS ITS DIAMETER IS 5 MM. ITS LENGTH IS ABOUT 15 CM. THIS IS NOT THE 6 MM X 15 CM DEVICE THAT WAS REPORTED TO BE RETURNED IN THE COMPLAINT DESCRIPTION. THE ENDOPROSTHESIS HAS DRIED BLOOD THROUGHOUT. THERE WERE MULTIPLE POINTS IN THE ENDOPROSTHESIS WHERE THE STENT WAS DETACHED FROM THE GRAFT AND BODY TAPE WAS DELAMINATED FROM THE ENDOPROSTHESIS. THE 5 MM X 15 CM DELIVERY CATHETER DID NOT HAVE AN ENDOPROSTHESIS NOR KNOB ATTACHED TO IT. APPROXIMATELY 11 CM OF DEPLOYMENT LINE WAS PRESENT COMING OUT OF THE TRANSITION. APPROXIMATELY 12 CM OF DEPLOYMENT LINE WAS PRESENT COMING OUT OF THE HUB. EACH END OF THE DEPLOYMENT LINE APPEARED TO BE BROKEN OR CUT. THERE WERE MULTIPLE KINKS AND TWISTS THROUGHOUT THE DISTAL SHAFT, ON WHICH THE ENDOPROSTHESIS WAS MOUNTED. THERE WAS ABOUT 12 CM OF COLUMNAR FAILURE ON THE DUAL LUMEN CATHETER SHAFT NEAR THE TRANSITION. THE 6 MM X 15 CM DELIVERY CATHETER DID NOT HAVE A MOUNTED ENDOPROSTHESIS. THE DELIVERY CATHETER ALSO DID NOT HAVE ANY DEPLOYMENT LINE NOR KNOB PRESENT. TWO KINKS WERE PRESENT ON THE DISTAL SHAFT APPROXIMATELY 5 CM FROM THE TRANSITION. BASED ON THE DEVICE EXAMINATION PERFORMED, NO MANUFACTURING ANOMALIES WERE IDENTIFIED. THE EXPLANT ANALYSIS STATED THAT SUBMITTED UNFIXED WAS ONE GORE® VIABAHN® ENDOPROSTHESIS. THE LUMEN OF THE DEVICE WAS WIDELY PATENT. THE LUMINAL AND ABLUMINAL DEVICE SURFACES WERE DEVOID OF TISSUE EXCEPT RED/BROWN STAINING CONSISTENT WITH DRIED BLOOD. HISTOPATHOLOGICAL EXAMINATION WAS NOT PERFORMED DUE TO THE PAUCITY OF ADHERENT TISSUE. THE DEVICE WAS SUBJECTED TO AN ENZYMATIC DIGESTION PROCESS TO REMOVE BIOLOGIC DEBRIS. FOLLOWING DIGESTION THE DEVICE WAS EXAMINED FOR MATERIAL DISRUPTIONS WITH THE AID OF A STEREOMICROSCOPE. THERE ARE DISTORTIONS OF THE WIRE FRAME AND ASSOCIATED BONDING FILM DISRUPTIONS CONSISTENT WITH THE EXPLANT PROCESS. THERE IS NO EVIDENCE OF DEVICE CONSTRICTION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: (B)(6) 2016 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE LOT 12940647 A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. AN ENGINEERING EVALUATION AND EXPLANT ANALYSIS IS CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2016, TWO GORE BIABAHN ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE WERE USED FOR THE TREATMENT OF A SUPER FEMORAL ARTERY ANEURYSM. THE FIRST 6MM X 15CM DEVICE WAS SUCCESSFULLY DEPLOYED. IT WAS REPORTED TO GORE THAT THE SECOND 5MM X 15CM DEVICE ONLY PARTIALLY DEPLOYED. IT WAS STATED THAT THE PARTIALLY DEPLOYED DEVICE OCCLUDED BOTH DEVICES. THE PATIENT WAS TAKEN TO SURGERY THE NEXT DAY TO REMOVE THE STENT GRAFT THAT WAS PARTIALLY DEPLOYED. THE FULLY DEPLOYED DEVICE REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, TWO GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE WERE USED FOR THE TREATMENT OF A SUPER FEMORAL ARTERY ANEURYSM. THE FIRST 5MM X 15CM DEVICE WAS SUCCESSFULLY DEPLOYED DISTALLY. IT WAS REPORTED TO GORE THAT THE SECOND 6MM X 15CM DEVICE ONLY PARTIALLY DEPLOYED. IT WAS STATED THAT THE PARTIALLY DEPLOYED DEVICE OCCLUDED BOTH DEVICES. THE PATIENT WAS TAKEN TO SURGERY THE NEXT DAY TO REMOVE THE STENT GRAFT THAT WAS PARTIALLY DEPLOYED. THE FULLY DEPLOYED DEVICE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731051 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 13664815

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention