BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 3982696 · Received June 16, 2014

    Report

    Report Number
    2020394-2014-00266
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO ENSURE COMPLIANCE TO 21 CFR 803.50 A RETROSPECTIVE REVIEW OF THIS FILE WAS CONDUCTED TO DETERMINE IF GOOD FAITH EFFORTS WERE MADE TO OBTAIN THE REQUIRED INFORMATION AND/OR AN EXPLANATION OF WHY ANY REQUIRED INFORMATION WAS NOT PROVIDED. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE WITH THE FACILITY TO OBTAIN ANY INFORMATION PERTAINING TO THE PATIENT, PRODUCT, AND/OR PROCEDURAL DETAILS (E.G. DATE OF THE EVENT, RELEVANT TEST DATA, RELEVANT HISTORY, LOT #, CATALOG #, IMPLANT AND/OR EXPLANTED DATES, AND CONCOMITANT PRODUCT(S) OR THERAPY) THAT WERE NOT PREVIOUSLY OBTAINED DURING THE INITIAL INVESTIGATION. THE USER FACILITY REPORTED THAT IT IS UNABLE TO PROVIDE ANY FURTHER PATIENT OR PROCEDURAL DETAILS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED. THE LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. THE STENT GRAFT WAS RETURNED PARTIALLY DEPLOYED AND PROTRUDED APPROXIMATELY 4MM FROM THE DISTAL END OF THE OUTER CATHETER. AN ATTEMPT TO DEPLOY THE STENT GRAFT WAS NOT SUCCESSFUL, AS THE INNER CATHETER COULD NOT BE MOVED RELATIVE TO THE OUTER SHEATH. BASED ON THESE RESULTS, THE INVESTIGATION IS CONFIRMED FOR PARTIAL DEPLOYMENT. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFO. IT IS UNK WHETHER PT AND /OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED IN AN UPPER ARM A-V GRAFT. THE DEVICE WAS REMOVED AND A NEW STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PT INJURY. UPON RETURN OF THE DEVICE TO BARD FOR EVAL, THE STENT GRAFT WAS NOTED TO BE PARTIALLY DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353518 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANXL1861

    Patients

    Seq Age Sex Outcome Treatment
    1