BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TEX® VASCULAR GRAFT

    MDR report key: 5468617 · Received February 29, 2016

    Report

    Report Number
    2017233-2016-00189
    Event Type
    Death
    Date Received
    February 29, 2016
    Date of Event
    June 28, 2013
    Report Date
    February 19, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. 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 CONCLUSION CAN BE DRAWN. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE, "OUTCOMES OF SYSTEMIC TO PULMONARY ARTERY SHUNTS IN PATIENTS WEIGHING LESS THAN 3 KG: ANALYSIS OF SHUNT TYPE, SIZE, AND SURGICAL APPROACH", ACCEPTED FOR PUBLICATION SEPTEMBER 23, 2013, READ AT THE 39TH ANNUAL MEETING OF THE WESTERN THORACIC SURGICAL ASSOCIATION COEUR D'ALENE, IDAHO, PRINTED IN THE AMERICAN ASSOCIATION FOR THORACIC SURGERY VOLUME 147, NUMBER 2, FEBRUARY 2014 (HTTP://DX.DOI.ORG/10.1016/J.JTCVS.2013.09.055), ONE PATIENT EXPIRED DUE TO SHUNT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124028 GORE TEX® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Death