BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 7182202 · Received January 11, 2018

    Report

    Report Number
    2247686-2018-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2018
    Date of Event
    December 13, 2017
    Report Date
    January 11, 2018
    Manufacturer
    ARTEGRAFT, INC
    Product Code
    LXA
    UDI-DI
    00316837000299
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 001: A PORTION OF THE COMPLAINT GRAFT (LOT: 17G195-007) WHICH WAS NOT IMPLANTED WAS RETURNED TO ARTEGRAFT, INC. FOR EVALUATION. THE CALCULATED WALL THICKNESS ON EACH END OF THE RETURNED GRAFT PORTION WAS VERIFIED TO BE WITHIN THE REQUIRED PRODUCT SPECIFICATIONS; THEREFORE, THE ISSUE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT ARTEGRAFT (COLLAGEN VASCULAR GRAFT) LOT 17G195-007 WAS NOT RETURNED TO ARTEGRAFT, INC. FOR EVALUATION AS IT WAS "REPAIRED" BY THE SURGEON DURING IMPLANT. 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 17G195 PASSED ALL OF THE REQUIREMENTS INCLUDING WALL THICKNESS, PRESSURE TESTING, STERILITY TESTING, AND FINAL VISUAL INSPECTION PRIOR TO FINAL RELEASE TO FINISHED GOODS. THE CUSTOMER'S ALLEGATION WAS NOT ABLE TO BE CONFIRMED AS THE GRAFT REMAINS IMPLANTED. NO ADDITIONAL COMPLAINTS FROM THIS PRODUCT BATCH WERE REPORTED TO DATE. NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO THIN GRAFT WALL AND SUTURE HOLE BLEEDING. 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

    RECEIVED A PHONE CALL FROM AN APPROVED DISTRIBUTOR STATING THAT DURING THE IMPLANT OF THE ARTEGRAFT (COLLAGEN VASCULAR GRAFT) A SURGEON HAD "DIFFICULTY SUTURING". IN FOLLOW-UP COMMUNICATIONS IT WAS CLARIFIED THAT THE GRAFT WAS "BLEEDING AFTER EVERY STITCH" EVEN USING 7-0 SIZE SUTURE. THE SURGEON STATED THAT THE GRAFT THICKNESS WAS NOT THE ACCEPTABLE MEASUREMENT; ONE END WAS OK, BUT THE OTHER END WAS "WAY TOO THIN". "THIS CAUSED MAJOR SUTURE HOLE BLEEDING AFTER EVERY STICH." THE SURGEON "OVERSEWED AND THE BLEEDING WAS CONTROLLED". THE IMPLANT WAS COMPLETED AND THE PATIENT WAS STABLE. THE SURGEON HAS SEEN THE PATIENT IN THE OFFICE AFTER THE IMPLANT AND THE "GRAFT IS FUNCTIONING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26691 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC AG740 17G195-007 00316837000299

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention