BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 9998316 · Received April 24, 2020

    Report

    Report Number
    2247686-2020-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2020
    Date of Event
    March 24, 2020
    Report Date
    May 27, 2020
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    UDI-DI
    00316837000244
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP 001. SECTION B3: DATE OF THE EVENT WAS CORRECTED FROM (B)(6) 2020 TO (B)(6) 2020. SECTION G4: ADDITIONAL INFORMATION WAS RECEIVED ON 05/04/2020. CURRENT PATIENT STATUS WAS REPORTED AS STABLE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT ARTEGRAFT (COLLAGEN VASCULAR GRAFT) LOT 19L318-027 WAS NOT RETURNED TO ARTEGRAFT, INC. FOR EVALUATION AS IT WAS REPAIRED, TRIMMED, AND IMPLANTED. A REVIEW OF THE PRODUCTION BATCH RECORD WAS PERFORMED; NO ANOMALIES WERE IDENTIFIED. ALL GRAFTS RELEASED FROM PRODUCT BATCH 19L318 PASSED ALL OF THE REQUIREMENTS INCLUDING PRESSURE TESTING AND WALL THICKNESS PRIOR TO FINAL RELEASE TO FINISHED GOODS. THE CUSTOMER'S ALLEGATION OF A GRAFT "HOLE" PRE-IMPLANT WAS VISUALLY VERIFIED VIA PHOTOGRAPH. A REVIEW OF THE PHOTOGRAPHS INDICATES A CUT/SLIT IN THE GRAFT WALL. AS 100% OF GRAFTS MANUFACTURED ARE PRESSURE TESTED AND THEN VISUALLY INSPECTED BY TWO TECHNICIANS PRIOR TO RELEASE, IT IS HIGHLY UNLIKELY THAT A DEFECT OF THIS NATURE WOULD HAVE PASSED THE INSPECTION RELEASE PROCESS. AS THIS IS A KNOWN POSSIBLE ISSUE, ARTEGRAFT, INC. INSTRUCTIONS FOR USE INCLUDE INSTRUCTIONS FOR PRESSURE TESTING EACH GRAFT PRIOR TO IMPLANT. THE PREPARATION FOR IMPLANT SECTION STATES, "ARTEGRAFT IS MANOMETRY PRESSURE TESTED AND QUALITY INSPECTED. BEFORE IMPLANTING, OCCLUDE ONE END OF GRAFT AND PRESSURE TEST WITH SYRINGE FILLED WITH SALINE SOLUTION." A LIKELY POSSIBLE ROOT CAUSE IS THAT THE GRAFT WAS MISTAKENLY DAMAGED AT THE CUSTOMER SITE DURING THE PREIMPLANT PREPARATION STEPS. ADDITIONAL FOLLOW-UP INFORMATION WAS REQUESTED INCLUDING CURRENT PATIENT STATUS, PATIENT INFORMATION, AND ADDITIONAL DETAILS ABOUT WHEN AND HOW THE ISSUE WAS DISCOVERED. TO DATE, ADDITIONAL REQUESTED INFORMATION HAS NOT BEEN PROVIDED. TO DATE, NO ADDITIONAL COMPLAINTS WERE REPORTED FROM THIS PRODUCT BATCH, 19L318. 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 PRIOR TO IMPLANT AS HAVING A "HOLE". IT WAS ALSO NOTED THAT THE GRAFT "SEEMED THINNER THAN NORMAL". THE SURGEON WAS ABLE TO REPAIR THE GRAFT HOLE WITH SUTURE BUT SUBSEQUENTLY TRIMMED, AND DISPOSED OF THAT PORTION OF THE GRAFT; THE REMAINING GRAFT LENGTH (LOT: 19L318-027) WAS SUCCESSFULLY IMPLANTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457970 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC. AG640 19L318-027 00316837000244

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR