BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® ACUSEAL VASCULAR GRAFT

    MDR report key: 6977893 · Received October 25, 2017

    Report

    Report Number
    2017233-2017-00554
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    April 29, 2017
    Report Date
    November 29, 2017
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K130215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE WAS ENTERED; DATE OF EVENT WAS SELECTED BASED ON CONGRESS PRESENTATION DATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED DEVICE WAS NOT RETURNED. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IN REVIEW OF PUBLISHED LITERATURE, THESE FINDINGS WERE NOTED: KENICHI HONMA ET AL., ¿STUDY OF OPERATIVE PROCEDURES AND POSTOPERATIVE OUTCOMES OF GORE ACUSEAL VASCULAR GRAFT.¿, (B)(6), ABSTRACTS, PAGE PS-229-1 (2017.04). BETWEEN DECEMBER 2015 AND AUGUST 2016, 36 PATIENTS UNDERWENT ARTERIOVENOUS GRAFT SURGERY USING A GORE® ACUSEAL VASCULAR GRAFT. THE GRAFTS WERE PLACED IN THE FOREARM (17 PATIENTS), IN THE UPPER ARM (17 PATIENTS) OR IN THE THIGH (TWO PATIENTS). THE ARTICLE STATED THAT SINCE THE OUTER DIAMETER OF THE ACUSEAL VASCULAR GRAFT IS THICK, RISK OF WOUND DEHISCENCE IS HIGH AND ATTENTION FOR GRAFT INFECTION IS NEEDED. IT WAS REPORTED THAT SOMETIME AFTER THE IMPLANT PROCEDURE (DATE UNKNOWN), ONE PATIENT WITH IMPLANT IN THE UPPER ARM EXPERIENCED GRAFT INFECTION. THE ENTIRE GRAFT WAS EXPLANTED AND THE BRACHIAL ARTERY WAS LIGATED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755541 GORE® ACUSEAL VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention