BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 7064838 · Received November 28, 2017

    Report

    Report Number
    2017233-2017-00623
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 1, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: ATTACHED IS VOLUNTARY MEDWATCH #UF/REPORT # (B)(4) RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO FURTHER INVESTIGATION IS POSSIBLE. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO GORE BY THE HOSPITAL MATERIALS MANAGER (HMM): "HYBRID DID NOT FULLY DEPLOY". THE HMM STATED THAT THE VENOTOMY NEEDED TO BE EXTENDED IN ORDER TO CUT OUT A PORTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844516 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 13534039

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other