BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTEGRAFT COLLAGEN VASCULAR GRAFT

    MDR report key: 3031156 · Received June 23, 2006

    Report

    Report Number
    2247686-2006-00001
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    June 16, 2006
    Report Date
    June 21, 2006
    Manufacturer
    ARTEGRAFT, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RECENT COMPLAINT/MDR RECORDS DO NOT REFLECT ANY SIMILAR TRENDING, INDICATING A PROCESS OR DESIGN ISSUE AT THIS TIME. REVIEW OF THE BATCH RECORD IN QUESTION DOES NOT INDICATE ANY SPECIFIC PROCESS OR TESTING ISSUES WHICH MAY LEAD TO FURTHER INVESTIGATIONS AT THIS TIME, ARTEGRAFT DOES REVIEW COMPLAINT TRENDING FOR SIMILAR TYPES OF PROBLEMS AND ISSUES ON A PERIODIC BASIS. THIS WILL CONTINUE.

    Description of Event or Problem · 1

    PRODUCT CODE AG730 (7MMOD X 30CM LENGTH) COLLAGEN GRAFT WAS IMPLANTED INTO PATIENT'S LEFT FOREARM FOR DIALYSIS PURPOSES. ARTERY TO VEIN. AFTER THE IMPLANT, EXCELLENT FLOW WAS INDICATED UNTIL THE BLOOD HIT A SPECIFIC GRAFT LOCATION (LABELED A) ON THE DOCTOR'S SKETCH. THE DOCTOR CONSIDERED A BLOCKAGE OF SOME SORT, WHICH HE CALLED A "WEB" WITHIN THE INNER LUMEN. AFTER CONFIRMING NO BLOOD FLOW AT SITE "A" THE GRAFT WAS OPENED AND THE DESCRIBED "WEB MATERIAL" WAS EXCISED". THE GRAFT WAS RE-CLOSED WITH 7-0 PROLINE SUTURE. THE DOCTOR FOUND THAT THERE WAS STILL NO BLOOD FLOW PAST SKETCH "B" IN HIS DESCRIPTION. DOCTOR AND STAFF INSPECTED FOR KINKS OR OTHER BLOOD FLOW ISSUES. THE SKETCHES ARE IN ARTEGRAFT'S MDR FILE. AFTER SEVERAL ATTEMPTS TO MAKE THE GRAFT PERFORM PROPERLY, THE ORIGINAL GRAFT WAS EXPLANTED AND REPLACED WITH AN EPTFE GRAFT. (UNK SUPPLIER). ON (B)(6) 2006 PT SEEMS TO BE DOING WELL. NO SIGNIFICANT GRAFT ISSUES. ON (B)(6) 2006 PT SEEMS TO BE DOING WELL. NO ON-GOING SIGNIFICANT GRAFT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTEGRAFT COLLAGEN VASCULAR GRAFT VASCULAR GRAFT LXA ARTEGRAFT, INC. AG 730 05L 197-008

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention THERAPY| EPTFE VASCULAR GRAFT IMPLANTED WITH ATTENDANT