BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTEGRAFT

    MDR report key: 19530123 · Received June 13, 2024

    Report

    Report Number
    2247686-2024-00004
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 12, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    LXA
    PMA / PMN Number
    N16837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GRAFT WAS NOT RECEIVED FOR EVALUATION AND THE ISSUE WAS NOT ABLE TO BE CONFIRMED. FOLLOW-UP PATIENT INFORMATION INCLUDING STATUS, LOT NUMBERS USED, AND IMPLANTATION DATES WERE PROVIDED ON (B)(6) 2024. ADDIITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 THAT STATES THE PATIENT CLOTTED AGAIN SO THE DOCTOR ENDED UP "LIGHTING" AND EXCISING THE GRAFT. NO RELATED NCMR/CAPA WAS IDENTIFIED; NO CONFIRMED COMPLAINT TREND RELATED TO THIS ISSUE WAS IDENTIFIED. LEMAITRE CURRENT RISK CONTROLS WERE DETERMINED TO BE SUFFICIENT AT THIS TIME. A REVIEW OF THE DHR WAS PERFORMED, NO ISSUES WERE NOTED AND WALL THICKNESS MET SPECIFICATIONS. WE REMAIN INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE ISSUE, BUT BASED ON THE DOCUMENTATION AND COMPLAINT HISTORY REVIEW, WE DO NOT BELIEVE THERE IS A SYSTEMIC ISSUE WITH THESE DEVICES.

    Description of Event or Problem · 0

    ARTEGRAFT PLACED ON (B)(6) 2024, GRAFT CLOTTED AND THROMBECTOMY WENT WELL, GRAFT WAS ACCESSED POST INTERVENTION (BY SURGEON) AND WAS LEAKY AND GRAFT WALL SEEMED THIN "SEEMED DISINTEGRATED", GRAFT DID NOT SEEM TO INCORPORATE LIKE AG TYPICALLY DOES, PATIENT HAS NO INFECTION AND IS INPATIENT CURRENTLY (FOR OTHER REASONS) BUT ON IV ANTIBIOTICS. THE GRAFT WAS REPORTED AS A PRIMARY GRAFT. IT WAS FLUSHED EIGHT TIMES WITH SALINE SOLUTION AND PRESSURIZED WITH HEPARINIZED SOLUTION WITH CLAMP. THE GRAFT WAS IMPLANTED ON (B)(6) 2024 AND STARTED CANNULATION ON (B)(6) 2024. AN ANGIOPLASTY AND THROMBECTOMY WERE PERFORMED TO THE GRAFT ON (B(6) 2024. THE GRAFT WAS DESCRIBED AS "FAIRLY THIN" BUT NO OBVIOUS INFECTION WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT IT SEEMS LIKE THE GRAFT DID NOT INCORPORATE WELL AND WAS LEAKING FROM NEEDLE HOLES; THE GRAFT IS ALSO FAIRLY THINNER THAN IMPLANTATION. THE GRAFT WAS REPORTED AS STILL PATENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 THAT STATES THE PATIENT CLOTTED AGAIN AND THE DOCTOR EXPLORED. IT SEEMED LIKE A SEROMA AGAIN SO THE DOCTOR ENDED UP "LIGHTING" AND EXCISING THE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937008 ARTEGRAFT COLLAGEN VASCULAR GRAFT LXA LEMAITRE VASCULAR, INC. AG640 23C153-016

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention