BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 3042832 · Received March 13, 2013

    Report

    Report Number
    2017233-2013-00139
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    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

    THE REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. BASED ON SPECIMEN RETURN ANALYSIS, CLOSE EXAM OF THE DEVICE DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT CAUSED THE FAILED DEPLOYMENT. THE EXAM FOUND NO ANOMALIES ATTRIBUTABLE TO THE MFR OF THE DEVICE.

    Description of Event or Problem · 1

    A GORE HYBRID VASCULAR GRAFT WAS USED AS A DIALYSIS ACCESS GRAFT. THE INTENDED PLACEMENT WAS FROM THE BASILIC VEIN TO THE AXILLARY ARTERY USING A STANDARD CUT-DOWN IMPLANTATION TECHNIQUE. DURING THE NITINOL REINFORCED SECTION (NRS) DEPLOYMENT, THE NRS REPORTEDLY FOLDED IN ON ITSELF AND PARTIALLY DEPLOYED. THE GRAFT WAS REMOVED AND ANOTHER HYBRID VASCULAR GRAFT WAS IMPLANTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106463 GORE HYBRID VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 10697538

    Patients

    Seq Age Sex Outcome Treatment
    1