BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 2840587 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07101
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    April 16, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2012-07100. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, A FILLING DEFECT OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIA) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST TARGET LESION WAS LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG) TO PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX) WITH 99% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE LESION WAS CROSSED WITH AN EZ FILTER WIRE WHICH WAS DEPLOYED WITHOUT DIFFICULTY AND A 3.5X16MM ION STENT WAS IMPLANTED, FOLLOWING THIS A 'DISTAL FILLING DEFECT' WAS SEEN AT THE MARGIN WHICH WAS TREATED WITH ANOTHER 3.5X12MM ION STENT OVERLAPPING THE PREVIOUSLY PLACED STENT, WITH 0% RESIDUAL STENOSIS. THE 2ND TARGET LESION WAS LOCATED IN THE DISTAL SAPHENOUS VEIN GRAFT (SVG) TO PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX) WITH 75% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 3.5X12MM ION STENT, WITH 0% RESIDUAL STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE UNK524

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention