BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 2912986 · Received December 5, 2012

    Report

    Report Number
    2017233-2012-00809
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED BASED ON ENGINEERING EVALUATION COMPLETED ON (B)(4) 2012. REVIEW OF DEVICE MANUFACTURING RECORD HISTORY CONFIRMED DEVICE MET-PRE-RELEASE SPECIFICATIONS. TWO FLAT FILMS OF ANGIOGRAMS WERE RECEIVED. HOWEVER, THE IMAGES WERE NOT ABLE TO BE SCANNED OR EVALUATED IN ANY OF THE IMAGING SERVICES SOFTWARE. ENGINEER EVALUATION STATED THE EXAMINATION DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT THE CAUSED THE FAILED DEPLOYMENT. THE EXAMINATION FOUND NO ANOMALIES ATTRIBUTABLE TO THE MANUFACTURE OF THE DEVICE. INVESTIGATION IS INCONCLUSIVE.

    Description of Event or Problem · 1

    DURING AN A-V ACCESS PROCEDURE IN THE PT'S LEFT ARM, A GORE HYBRID VASCULAR GRAFT WAS USED. THE HYBRID GRAFT WAS ADVANCED USING A PEEL-AWAY SHEATH WITHOUT THE AID OF A GUIDEWIRE. AS THE HYBRID GRAFT WAS ADVANCED, THE NITINOL REINFORCE SECTION (NRS) STARTED TO BOWSTRING. THE DEPLOYMENT LINE GOT HUNG UP ON THE NRS AND WHEN THE LINE WAS PULLED, IT BROKE. THE GRAFT WAS REMOVED AND A GORE PROPATEN VASCULAR GRAFT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THE PT IS FINE WITH NO ADVERSE CONSEQUENCES. ON (B)(6) 2012, OUR ENGINEERING EVALUATION STATED THE HYBRID DEVICE WAS PARTIALLY DEPLOYED, AND THE NITINOL REINFORCED SECTION (NRS) WAS CURLED UPON ITSELF. SEVERAL NRS STRUTS WERE PUSHED THROUGH THE ZIPPER, TRAPPING THE ZIPPER FIBERS. A PORTION, FROM THE DISTAL END ROW OF THE NRS, GOT CAUGHT UP UNDER THE DEPLOYMENT LINE. TWO OF THE STRUTS WERE DELAMINATED. BASED ON THE ENGINEERING EVALUATION, THE PARTIAL DEVICE EXPANSION LIKELY HAPPENED DURING DEVICE ADVANCEMENT INTO THE SHEATH/VESSEL. AS A RESULT, THIS REPORT IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HYBRID VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 10570832

    Patients

    Seq Age Sex Outcome Treatment
    1