BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 7138875 · Received December 21, 2017

    Report

    Report Number
    2247686-2017-00012
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 23, 2017
    Report Date
    December 21, 2017
    Manufacturer
    ARTEGRAFT, INC
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE REQUESTS WERE MADE TO RETRIEVE ADDITIONAL INFORMATION; HOWEVER, TO DATE, NO ADDITIONAL INFORMATION WAS PROVIDED. PRODUCT CODE, LOT NUMBER, DATE OF IMPLANT, EXACT DATE OF THE EVENT, PATIENT IDENTIFIER AND INFORMATION WERE NOT PROVIDED. A REVIEW OF THE PRODUCTION BATCH RECORDS WAS NOT ABLE TO BE COMPLETED AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. THE INITIAL REPORT STATES THAT THE PATIENT WAS STABLE. ANEURYSM IS A KNOWN ISSUE; ARTEGRAFT, INC. IFU ADVERSE REACTION SECTION STATES THAT "TRUE ANEURYSMS HAVE BEEN REPORTED. IN VIEW OF THIS, PATIENTS WITH IMPLANTED ARTEGRAFTS SHOULD BE OBSERVED SO THAT APPROPRIATE ACTION CAN BE TAKEN IF AN ANEURYSM SHOULD OCCUR. THIS ADVERSE REACTION SHOULD ALSO BE CONSIDERED WHEN TREATING CONDITIONS IN WHICH EXTENDED PERIODS OF IMPLANTATION ARE EXPECTED". TO DATE, NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO ANEURYSMAL GRAFTS. ALL PRODUCT QUALITY AND CLINICAL ISSUES 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 A PHONE CALL FROM A VASCULAR SURGEON STATING THAT IN 2013 TWO PATIENTS HAD A FEMORAL POPLITEAL BYPASS PROCEDURE WITH ARTEGRAFT (COLLAGEN VASCULAR GRAFT); THE GRAFTS WERE REPORTED AS BECOMING ANEURYSMAL. THIS FILE WILL CAPTURE PATIENT 1 OF 2. THE PATIENT WAS REPORTED AS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919610 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1