BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEGRAFT

    MDR report key: 6996812 · Received November 2, 2017

    Report

    Report Number
    2247686-2017-00010
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 2, 2017
    Manufacturer
    ARTEGRAFT, INC
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE REQUESTS WERE MADE TO THE INITIAL REPORTER (DISTRIBUTOR) AND THE IMPLANTING SURGEON FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. PRODUCT CODE, LOT NUMBER, DATE OF IMPLANT, EXACT DATE OF THE EVENT, PATIENT IDENTIFIER AND INFORMATION WERE NOT PROVIDED. A REVIEW OF THE PRODUCTION BATCH RECORDS WAS NOT ABLE TO BE COMPLETED AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. ARTEGRAFT, INC. SCIENTIFIC ADVISOR (QUALIFICATION: M.D., F.A.C.S.) REVIEWED THE CASE DETAILS BUT WAS NOT ABLE TO DETERMINE POSSIBLE ROOT CAUSE WITHOUT ADDITIONAL INFORMATION. THE INITIAL REPORT STATES THAT THE SURGEON WAS ABLE TO SUCCESSFULLY PATCH THE GRAFT. NO CONFIRMED COMPLAINT TREND WAS IDENTIFIED RELATED TO HYPERPLASIA. ALL PRODUCT QUALITY AND CLINICAL ISSUES 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. APPROVED DISTRIBUTOR REPORTED THE ISSUE ON BEHALF OF DR. (B)(6) (VASCULAR SURGEON AT (B)(6) HOSPITAL). DR. (B)(6), HAD RECENTLY IMPLANTED A PRIMARY COLLAGEN VASCULAR GRAFT (ARTEGRAFT) AS A LOWER ARM LOOP IN A HYPERTENSIVE (B)(6) FEMALE. THE PATIENT DEVELOPED HYPERPLASIA AT THE VENOUS ANASTOMOSIS WITH ARM SWELLING AND A THICK "PEEL". THE SURGEON WAS ABLE TO SUCCESSFULLY PATCH THE GRAFT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776748 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA ARTEGRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention