BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEGRAFT

    MDR report key: 7247267 · Received February 7, 2018

    Report

    Report Number
    2247686-2018-00004
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    December 11, 2017
    Report Date
    February 7, 2018
    Manufacturer
    ARTEGRAFT, INC
    Product Code
    LXA
    UDI-DI
    00316837000244
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT 2 OF 2. REFER TO MDR'S 2247686-2018-00002 AND 2247686-2018-00003 FOR PATIENT 1 OF 2. THE ARTEGRAFT (COLLAGEN VASCULAR GRAFTS) WAS NOT RETURNED TO ARTEGRAFT, INC. FOR EVALUATION. A REVIEW OF THE PRODUCTION BATCH RECORD WAS PERFORMED; NO ANOMALIES WERE IDENTIFIED. ALL GRAFTS RELEASED FROM PRODUCT BATCH 17G218 PASSED ALL OF THE REQUIREMENTS INCLUDING PRESSURE TESTING AND STERILITY TESTING PRIOR TO FINAL RELEASE TO FINISHED GOODS. IN FOLLOW-UP CONVERSATIONS BETWEEN THE DISTRIBUTOR REPRESENTATIVE AND THE SURGEONS' STAFF AT (B)(6) HOSPITAL, IT WAS STATED THAT THE TAMPER EVIDENT SEAL WAS IN PLACE ON THE BOX , THE SHRINK WRAP WAS PRESENT ON THE TUBE PRIOR TO USE, AND THE GRAFT WAS PREPARED PER THE IFU PRIOR TO USE. ARTEGRAFT, INC. CHIEF MEDICAL OFFICER (QUALIFICATION: M.D., F.A.C.S.) REVIEWED THE CASE DETAILS AND STATED THAT " IN THE EVENT THAT A WOUND INFECTION OCCURS IN THE AREA OF THE ARTEGRAFT, INCREASED SURVEILLANCE MUST BE UNDERTAKEN. GRAFT IS COLLAGEN. COLLAGEN MAY BREAK DOWN IN THE PRESENCE OF PSEUDOMONAS, MRSA, E. COLI." ARTEGRAFT, INC. IFU DOSAGE AND ADMINISTRATION SECTION PROVIDES INSTRUCTIONS FOR ASEPTICALLY REMOVING THE ARTEGRAFT FROM ITS CONTAINER. ADDITIONALLY, THE ADVERSE REACTION SECTION STATES "DISRUPTION OF ANASTOMOSES, ESPECIALLY IN THE PRESENCE OF INFECTION, HAS BEEN OBSERVED AND, IN A FEW CASES, TRANSIENT LOW GRADE FEVER, THE ETIOLOGY, OF WHICH HAS NOT BEEN OBVIOUS, HAS BEEN EXPERIENCED." NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO THE ISSUE. ALL PRODUCT QUALITY AND CLINICAL ISSUES WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING.

    Description of Event or Problem · 1

    ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON (DR. (B)(6)) STATING THAT HE RECENTLY HAD 2 PATIENTS THAT ACQUIRED INFECTIONS ROUGHLY 2 WEEKS POST-OP ARTEGRAFT (COLLAGEN VASCULAR GRAFT) IMPLANT FOR PERIPHERAL USE. THIS FILE WILL CAPTURE PATIENT 2 OF 2. ON (B)(6) 2017 THE PATIENT HAD AN ARTEGRAFT IMPLANTED FOR FEMORAL POPLITEAL AT THE RIGHT KNEE. THE PATIENT PRESENTED TO THE ER AT (B)(6) ON (B)(6) 2017 WITH INFECTION, FEVER, SEVERELY SEPTIC AND TESTED POSITIVE FOR MULTIPLE INFECTIONS AT DISTAL/PROXIMAL END OF GRAFT. AFTER 2 DAYS ((B)(6) 2017) THE PATIENT WAS TRANSFERRED TO (B)(6) TO DR. (B)(6) FOR SURGERY. ON (B)(6) 2017 DR. (B)(6) DICTATION SAYS: INCISION, DRAINAGE AND WASHOUT OF RIGHT LOWER EXTREMITY THIGH AND GROIN. APPLIED WOUND VAC. ANTIBIOTIC BEAD PLACEMENT RIGHT THIGH AND GROIN. RIGHT THIGH MUSCLE FLAP COVERAGE OF GRAFT. INFECTION SPECIES WAS NOT NOTED. NO INFORMATION WAS PROVIDED REGARDING STATUS OF GRAFT AFTER THE PATIENT WAS TRANSFERRED BACK TO THE NURSING HOME. NO NOTES OF GRAFT FAILURE. PATIENT IS REPORTEDLY BACK AT THE HOSPITAL FOR "OTHER REASONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92983 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC AG640 17G218-001 00316837000244

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention