BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® HYBRID VASCULAR GRAFT

    MDR report key: 6209633 · Received December 28, 2016

    Report

    Report Number
    2017233-2016-00964
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 7, 2016
    Report Date
    January 18, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING WITHDRAWN (RETRACTED) BECAUSE IT WAS INCORRECTLY REPORTED AS A MALFUNCTION. AFTER FURTHER INFORMATION AND DISCUSSION, THE EVENT WAS CONCLUDED AS NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF DEVICE MANUFACTURING RECORD HISTORY CONFIRMED DEVICE MET PRE-RELEASE SPECIFICATIONS. THE DEVICE WAS DISCARDED BY USER FACILITY. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    PATIENT PRESENTED FOR AN ARTERIOVENOUS ACCESS PROCEDURE IN THE LEFT UPPER ARM. A GORE® HYBRID VASCULAR GRAFT WAS PLACED AT THE INTENDED TREATMENT SITE AND DEPLOYMENT WAS STARTED. THE NITINOL REINFORCED SECTION (NRS) OF THE GRAFT PARTIALLY EXPANDED WHEN THE DEPLOYMENT LINE GOT STUCK AND WOULD NOT RELEASE. THE PHYSICIAN CUT AND REMOVED THE SECTION OF THE NRS THAT WAS STILL CONSTRAINED. A NEW GORE® HYBRID VASCULAR GRAFT WAS IMPLANTED WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861130 GORE® HYBRID VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 15230748

    Patients

    Seq Age Sex Outcome Treatment
    1