BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 4161758 · Received July 24, 2014

    Report

    Report Number
    2020394-2014-00338
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 7, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 FACILITY WAS ABLE TO PROVIDE PATIENT DETAILS AND GAVE A CORRECTION TO THE ORIGINAL DATE OF EVENT, WHICH WAS UPDATED IN THE APPROPRIATE SECTIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE SAMPLE WAS RETURNED AND EVALUATED. THE OUTER CATHETER WAS STRETCHED 53MM FROM THE STRAIN RELIEF. THE STENT GRAFT WAS PARTIALLY DEPLOYED AND PROTRUDED APPROXIMATELY 1.5MM FROM THE TIP OF THE OUTER CATHETER. BENT STRUTS WERE NOTED IN THE UNDEPLOYED PORTION OF THE STENT GRAFT. AN ATTEMPT TO DEPLOY THE STENT GRAFT WAS NOT SUCCESSFUL, AS THE INNER CATHETER COULD NOT BE MOVED RELATIVE TO THE OUTER SHEATH. THE INVESTIGATION IS CONFIRMED FOR PARTIAL DEPLOYMENT, AS THE STENT GRAFT WAS RETURNED PARTIALLY DEPLOYED. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT GRAFT WAS UNABLE TO BE DEPLOYED IN AN AV GRAFT; THEREFORE, THE STENT GRAFT WAS EXCHANGED OVER THE GUIDEWIRE FOR NEW STENT GRAFT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433056 FLAIR ENDOVASCULAR STENT GRAFT MIH MIH BARD PERIPHERAL VASCULAR, INC. ANYA0036

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR