BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 4245524 · Received November 12, 2014

    Report

    Report Number
    2017233-2014-00590
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    September 22, 2014
    Report Date
    November 26, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. INVESTIGATION IS IN PROGRESS PENDING COMPLETION OF THE STERILIZATION DEVICE HISTORY REVIEW.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE STERILIZATION PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE STERILIZATION PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    A GORE® HYBRID VASCULAR GRAFT (HVG) WAS IMPLANTED DURING AN AV ACCESS PROCEDURE. THE GRAFT WAS IMPLANTED IN THE LEFT UPPER ARM WITH THE NITINOL REINFORCED SECTION (NRS) OF THE HVG PLACED IN A BARD FLAIR BARE METAL STENT WHICH EXTENDED INTO THE LEFT AXILLARY ARTERY. A FEW DAYS AFTER HVG IMPLANT, THE PHYSICIAN SUSPECTED AN ARTERIAL ANASTOMOSIS INFECTION. ON (B)(6) 2014, THE HGV WAS EXPLANTED. THE DISTAL PORTION OF NRS WAS UNABLE TO BE REMOVED FROM THE BARD FLAIR STENT AND HAD TO BE CUT FOR THE HGV REMOVAL. THE BARD FLAIR STENT AND A PORTION OF THE NRS REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730879 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 11180969

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention BARD FLAIR STENT