BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLAIR ENDOVASCULAR STENT GRAFT

    MDR report key: 3961155 · Received May 28, 2014

    Report

    Report Number
    2020394-2014-00243
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P060002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DID NOT HAVE ANY ADDITIONAL DETAILS TO PROVIDE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS. THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT NUMBER AND ISSUE TO DATE. ONE FLAIR ENDOVASCULAR STENT GRAFT WAS EVALUATED. THE OUTER CATHETER WAS STRETCHED AND A BEND WAS ALSO IDENTIFIED ON THE OUTER CATHETER. THE STENT GRAFT WAS PARTIALLY DEPLOYED AND PROTRUDED APPROXIMATELY 5MM FROM THE TIP OF THE OUTER CATHETER. DRIED BLOOD WAS OBSERVED BETWEEN THE OUTER CATHETER AND THE STENT GRAFT. A STRUT WAS NOTED TO BE EXPOSED AT THE DISTAL END OF THE PORTION OF DEPLOYED STENT GRAFT. NO KINKS WERE OBSERVED ON THE DEPLOYED 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. BASED ON THE EVAL, AN INVESTIGATION IS CONFIRMED FOR PARTIAL DEPLOYMENT, HOWEVER, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFO. IT IS UNK WHETHER PT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. THE INSTRUCTIONS FOR USE (IFU) STATE THAT DURING DEPLOYMENT OF THE STENT GRAFT, THE ENTIRE LENGTH OF THE DELIVERY SYSTEM SHOULD BE KEPT AS STRAIGHT AS POSSIBLE IN ORDER TO MITIGATE THE POTENTIAL FOR DISTAL STENT GRAFT MISPLACEMENT. ADDITIONALLY, SPECIFIC DIRECTIONS FOR PRECAUTIONS, INDICATIONS FOR USE, POTENTIAL COMPLICATIONS AND ADVERSE EVENTS ARE INCLUDED IN THE INSTRUCTIONS FOR USE (IFU). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT IN AN AV GRAFT, THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR A NEW STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314929 FLAIR ENDOVASCULAR STENT GRAFT MIH BARD PERIPHERAL VASCULAR, INC. ANXL0612

    Patients

    Seq Age Sex Outcome Treatment
    1