BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 6955649 · Received October 17, 2017

    Report

    Report Number
    2247686-2017-00009
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 27, 2017
    Report Date
    October 17, 2017
    Manufacturer
    ARTEGRAFT, INC
    Product Code
    LXA
    UDI-DI
    00316837000275
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT ARTEGRAFT (COLLAGEN VASCULAR GRAFT) LOT 17A008-009 WAS NOT RETURNED TO ARTEGRAFT, INC. FOR EVALUATION AS IT WAS REPAIRED AND IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. A REVIEW OF THE PRODUCTION BATCH DEVICE HISTORY RECORD WAS PERFORMED; NO ANOMALIES WERE IDENTIFIED. ALL GRAFTS RELEASED FROM PRODUCT BATCH 17A008 PASSED ALL OF THE REQUIREMENTS INCLUDING PRESSURE TESTING PRIOR TO FINAL RELEASE TO FINISHED GOODS. THE CUSTOMER'S ALLEGATION OF LEAKING GRAFT PRE-IMPLANT WAS NOT ABLE TO BE CONFIRMED AS THE GRAFT REMAINS IMPLANTED. AS THIS IS A KNOWN ISSUE, ARTEGRAFT, INC. INSTRUCTIONS FOR USE INCLUDE INSTRUCTIONS FOR PRESSURE TESTING EACH GRAFT PRIOR TO IMPLANT. THIS STEP WAS CORRECTLY COMPLETED BY THE IMPLANTING SURGEON. TO DATE, NO ADDITIONAL COMPLAINTS WERE REPORTED FROM THIS PRODUCT BATCH. THE COMPLAINT ISSUE WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS IDENTIFIED AS LEAKING DURING THE PRE-IMPLANT PRESSURE TESTING PER THE CORRESPONDING ARTEGRAFT IFU. THE SURGEON NOTED THAT THE GRAFT APPEARED TO HAVE A SMALL 1 MM HOLE IN IT AND WAS LEAKING IN THE MIDDLE OF THE GRAFT, NOT NEAR A BRANCH. THE SURGEON WAS ABLE TO REPAIR THE GRAFT HOLE WITH 6.0 PROLENE SUTURE AND THE GRAFT (LOT: 17A008-009) WAS SUCCESSFULLY IMPLANTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736280 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC AG730 17A008-009 00316837000275

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR