BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1786342 · Received August 5, 2010

    Report

    Report Number
    2134265-2010-03659
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FURTHER REPORTED THAT ON THE DATE OF THE INDEX PROCEDURE AND PRIOR TO DISCHARGE THE PATIENT EXPERIENCED HYPOTENSION. THE EVENT RESOLVED THE SAME DAY WITHOUT RESIDUAL EFFECTS. THE INVESTIGATOR ASSESSED THE HYPOTENSION EVENT AS POSSIBLY RELATED TO THE CAROTID WALLSTENT AND THE STUDY PROCEDURE, BUT UNRELATED TO THE FILTERWIRE EZ.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-03660. (B)(4). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCES AND AN ELEVATED TEMPERATURE. THE INDEX PROCEDURE TREATED A 72% STENOSED LESION AT THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY MEASURING 5.0X23MM. TREATMENT CONSISTED OF PLACEMENT OF A FILTERWIRE EZ DISTAL PROTECTION WIRE, DEPLOYMENT OF AN 8X36MM CAROTID WALLSTENT, AND POST DILATION RESULTING IN 10% RESIDUAL STENOSIS. ON THE SAME DAY AS THE INDEX PROCEDURE THE PATIENT EXPERIENCED BILATERAL VISUAL DISTURBANCES. NO ACTION WAS TAKEN AND THE EVENT RESOLVED THE SAME DAY WITHOUT RESIDUAL EFFECTS. ONE DAY POST PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED TEMPERATURE OF 102.4º F. AN UNSPECIFIED MEDICATION WAS ADMINISTERED AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900 0013330749

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention