BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANASTOCLIP GC VESSEL CLOSURE SYSTEM

    MDR report key: 2101436 · Received May 23, 2011

    Report

    Report Number
    1220948-2011-00003
    Event Type
    Injury
    Date Received
    May 23, 2011
    Report Date
    April 15, 2011
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    FZP
    PMA / PMN Number
    K091987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE LAST SIX MONTHS WERE REVIEWED AND ALL MANUFACTURING AND QUALITY INSPECTIONS WERE COMPLETED IN ACCORDANCE TO THE MANUFACTURING INSTRUCTIONS. WE HAVE NOT SEEN THIS TYPE OF COMPLAINTS BEFORE THE ANSTOCLIP GC DEVICES, AND WE BELIEVE IT WAS AN ISOLATED INCIDENT. THE ROOT CAUSE OF THE EVENT IS INCONCLUSIVE AT THIS TIME. LEMAITRE VASCULAR REPRESENTATIVE MADE MULTIPLE ATTEMPTS TO CONTACT THE PHYSICIAN FOR ADDITIONAL DETAILS. THE PHYSICIAN REFUSED TO DISCUSS THE INCIDENT DUE TO LACK OF TIME FOR THAT. PLEASE NOTE, THAT THE PHYSICIAN WAS NOT SURE WHAT WAS THE ROOT CAUSE OF THE EVENT: THE DEVICE OR PATIENT ANATOMY WAS CAUSE OF THE ADVERSE EVENT, AND HE DID NOT REPORT THIS EVENT TO THE EU REGULATORY BODY.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DOING THE CASE WITH THE ANASTOCLIP GC DEVICE FOR ANASTOMOSIS OF THE ILIAC/FEMORAL ARTERY. THE PHYSICIAN REPORTED THAT CLIPS BECAME LOOSE, AND THEY HAD TO AMPUTATE THE PATIENT'S LEG. THE PHYSICIAN WAS NOT SURE IF THE DEVICE OR PATIENT ANATOMY WAS CAUSE OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANASTOCLIP GC VESSEL CLOSURE SYSTEM ANASTOCLIP GC FZP LEMAITRE VASCULAR, INC. 4007-XX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1