BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT

    MDR report key: 6411261 · Received March 16, 2017

    Report

    Report Number
    2247686-2017-00002
    Event Type
    Malfunction
    Date Received
    March 16, 2017
    Date of Event
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    ARTEGRAFT,INC.
    Product Code
    LXA
    UDI-DI
    00316837000305
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT ARTEGRAFT (COLLAGEN VASCULAR GRAFT) LOT 15K263-027 WAS RETURNED TO ARTEGRAFT, INC. FOR EVALUATION. THE GRAFT INNER/OUTER DIAMETERS AND LENGTH WERE VERIFIED AS COMPARED TO THE DHR RELEASE DATA. THE THICKNESS OF THE GRAFT WALL WAS CALCULATED AS 0.5 MM; THIS IS WELL WITHIN THE REQUIRED ACCEPTABLE RANGE (0.25MM - 1.5MM) FOR THE PRODUCT. THE CUSTOMER'S ALLEGATION OF LEAKING GRAFT PRE-IMPLANT WAS CONFIRMED; DURING THE INVESTIGATIVE PRESSURE TESTING (PER ARTEGRAFT, INC. PROCESS SPECIFICATION) BUBBLES WERE SEEN COMING FROM A TRIBUTARY OF THE GRAFT. ADDITIONALLY, 4 INDENTS IN THE GRAFT WALL WERE OBSERVED. POSSIBLE ROOT CAUSES FOR THE LEAKING GRAFT MAY BE THAT A LIGATION SUTURE ON THE GRAFT TRIBUTARY LOOSENED. THE 4 INDENTS OBSERVED IN THE GRAFT WALL INDICATE THAT THE GRAFT MAY HAVE BEEN MISHANDLED DURING THE PRE-IMPLANT TESTING; POSSIBLY FROM THE CLAMP THAT WAS APPLIED BY THE SURGEON DURING THE PRE-IMPLANT TESTING. IT IS ALSO POSSIBLE THAT TOO MUCH FORCE WAS APPLIED DURING THE PRE-IMPLANT PRESSURE TEST. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE TOOLS/METHODS UTILIZED BY THE CUSTOMER FOR PRESSURE TESTING FOR THIS INCIDENT. AS THIS IS A KNOWN ISSUE, ARTEGRAFT, INC. INSTRUCTIONS FOR USE INCLUDE INSTRUCTIONS FOR PRESSURE TESTING EACH GRAFT PRIOR TO IMPLANT. CAPA WAS PREVIOUSLY INITIATED TO INVESTIGATE SIMILAR OCCURRENCES INVOLVING GRAFT WALL LEAKS PRE-IMPLANT. ADDITIONAL QUARTERLY ANALYSIS OF THE GRAFTS WAS IMPLEMENTED FOR POST-STERILIZATION DATA AND TRENDING. THIS GRAFT WAS MANUFACTURED IN 2015, PRIOR TO CAPA CLOSURE. 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. IN FOLLOW-UP CONVERSATIONS WITH THE RN FROM THE HOSPITAL IT WAS EXPLAINED THAT THE ISSUE WAS IDENTIFIED DURING THE GRAFT FLUSHING PROCESS; ONE END OF THE GRAFT WAS CLAMPED AND SALINE SOLUTION WAS BEING FLUSHED INTO THE LUMEN OF THE GRAFT. WHILE MARKING THE GRAFT WITH A DIRECTIONAL LINE, THE SURGEON NOTICED THE GRAFT WAS LEAKING MID-LENGTH NEAR A SIDE BRANCH. THE SURGEON DID NOT IMPLANT THE GRAFT (15K263-027). ANOTHER ARTEGRAFT AG745 WAS USED TO COMPLETE THE SURGERY WITHOUT ISSUE. NO PATIENT ADVERSE EVENTS WERE REPORTED. THE COMPLAINT GRAFT WAS RETURNED TO THE ORIGINAL STERILIZATION SOLUTION IN THE ARTEGRAFT PRODUCT CULTURE TUBE (WITHOUT THE PLASTIC SUPPORT ROD) AND WAS RETURNED TO ARTEGRAFT INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192244 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT,INC. AG745 15K263-027 00316837000305

    Patients

    Seq Age Sex Outcome Treatment
    1