BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESPAN EPTFE VASCULAR GRAFT

    MDR report key: 3482196 · Received November 14, 2013

    Report

    Report Number
    1220948-2013-00020
    Event Type
    Injury
    Date Received
    November 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    October 16, 2013
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DSY
    PMA / PMN Number
    K130016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WERE NOT ABLE TO VERIFY THE FAILURE MODE. THEREFORE, THE ROOT CAUSES(S) OF THE FAILURE REMAINS INCONCLUSIVE. WE HAVE CONTRACTED THE HOSPITAL AND PROVIDED INSTRUCTIONS FOR RETURN OF THE COMPLAINT DEVICE, HOWEVER, WE HAVE NOT YET RECEIVED THE SAMPLE OR ANY ADDITIONAL INFO FROM THE HOSPITAL/PHYSICIAN. A LOT HISTORY INVESTIGATION HAS NOT BEEN POSSIBLE SINCE NO LOT NUMBER AND/OR CATALOG NUMBER WAS PROVIDED. LEMAITRE VASCULAR INC. WILL CONTINUE TO INVESTIGATE THIS COMPLAINT AND SUBMIT A FOLLOW UP REPORT SHOULD MORE DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    LEMAITRE VASCULAR INC. RECEIVED INFO THAT ONE OF OUR EPTFE GRAFTS "CAME APART AND DISINTEGRATED. THE GRAFT HAD AN EDWARDS LABEL". THE GRAFT WAS EXPLANTED. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591327 LIFESPAN EPTFE VASCULAR GRAFT LIFESPAN EPTFE VASCULAR GRAFT DSY LEMAITRE VASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R