BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO BALLOON EXPANDABLE STENT

    MDR report key: 4811517 · Received May 22, 2015

    Report

    Report Number
    2020394-2015-00789
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    July 25, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    FGE
    PMA / PMN Number
    K052132
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FURTHER CLINICAL REVIEW WAS PERFORMED AND IDENTIFIED THIS EVENT TO BE MDR REPORTABLE PURSUANT TO 21 CFR PART 803. 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. THIS IS THE ONLY EVENT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. THE STENT WAS RETURNED ON THE BALLOON; THE STENT WAS DISLODGED FORWARD AND WAS COVERING THE DISTAL MARKER BAND, LOCATED APPROXIMATELY 1.2CM FROM THE DISTAL TIP OF THE CATHETER. THE BALLOON WAS EXAMINED UNDER MAGNIFICATION (MICROSCOPE 15X) AND STENT CRIMP MARKS WERE VISIBLE ON THE BALLOON. THIS INDICATES THAT THE STENT WAS CRIMPED ON THE APPROPRIATE BALLOON LOCATION DURING THE MANUFACTURING PROCESS. AN ATTEMPT WAS MADE TO INSERT THE STENT THROUGH AN IN-HOUSE 6FR TERUMO INTRODUCER SHEATH. THE STENT WAS EASILY MOVED AND COULD NOT BE INSERTED INTO THE INTRODUCER SHEATH. THE COMPLAINT INVESTIGATION IS CONFIRMED FOR A DISLODGED/DISLOCATED STENT. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFO. IT IS UNK IF PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. THE VALEO INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR USE OF THE DEVICE, AS WELL AS WARNINGS, PRECAUTIONS, AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. THE INFO PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFO AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFO, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON EXPANDABLE STENT DISLODGED FROM THE BALLOON AS IT WAS BEING INSERTED INTO THE INTRODUCER. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335359 VALEO BALLOON EXPANDABLE STENT FGE BARD PERIPHERAL VASCULAR, INC. GFWJ2435

    Patients

    Seq Age Sex Outcome Treatment
    1