BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFLEX?

    MDR report key: 3162754 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03858
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT HEART CATHETERIZATION TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE LESION WAS LOCATED IN THE "VERY" CALCIFIED OBTUSE MARGINAL. THEY COULD NOT DELIVER THE STENT AT FIRST. A 4.00 MM X 16 MM VERIFLEX STENT WAS ADVANCED THRU A NON BSC GUIDE CATHETER THEN THE STENT "STRIPPED OFF" THE BALLOON IN IT. THE PHYSICIAN ENDED UP "BALLOONING" THE VESSEL WITH THE STENT DELIVERY BALLOON (NO STENT ON THE SDS) AND WHEN HE GOT BACK INTO THE NON BSC GUIDE CATHETER, HE INFLATED THE BALLOON INSIDE OF IT SO THAT THE STENT WOULD STAY INSIDE IT. PULLED EVERYTHING OUT ALTOGETHER AND WAS ABLE TO RETRIEVE THE STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262415 VERIFLEX? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893416400 0015770094

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention