BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 3102774 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-02997
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    SAME CASE AS MFR: 2134265-2013-02993. IT WAS REPORTED THAT DURING AN INTERVENTION OF VEIN GRAFT TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 99% STENOSED, CONCENTRIC SHAPED, 14MM IN LENGTH, DE NOVO TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED, 4 MM IN DIAMETER RIGHT CORONARY ARTERY (RCA). THE FILTERWIRE EZ WAS PLACED IN THE VEIN GRAFT, AN ATTEMPT WAS MADE TO PRE-DILATE THE LESION WITH A FLEXTOME CUTTING BALLOON, BUT THE DEVICE WAS UNABLE TO LOAD ONTO THE WIRE. THEY SWITCHED IT WITH ANOTHER OF THE SAME DEVICE AND IT WORKED APPROPRIATELY. THEY USED USING IVUS TO LOOK AT THE VESSEL. A 4.0X16MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED AT THE PROXIMAL REGION OF THE VEIN GRAFT AND THE STENT WAS WELL APPOSED. AN ATTEMPTED WAS MADE TO RETRIEVE THE FILTER WIRE; HOWEVER, RESISTANCE WAS MET WHILE CROSSING THE STENT. THE FILTER WIRE WAS UNABLE TO BE RETRIEVED DUE TO STENT DEFORMATION AT THE PROXIMAL EDGE. THE FILTER WIRE WAS PULLED OUT AND WIRED THE STENT WITH A 0.14 FORTE GUIDE WIRE; THEY DILATED THE PROMUS STENT WITH A 4.5X15MM NC QUANTUM BALLOON CATHETER AND IMPLANTED A 4.5X12 VERIFLEX STENT OVER THE DAMAGED AREA OF THE PROMUS ELEMENT PLUS STENT. THEY POST- DILATED BOTH STENTS. IVUS WAS USED TO ASSURE THAT THE STENT WAS WELL APPOSED TO THE VESSEL WALL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203483 FILTERWIRE EZ¿ TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention GUIDE WIRE: .014 FORTE