BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ¿

    MDR report key: 3003920 · Received March 14, 2013

    Report

    Report Number
    2134265-2013-01682
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 14, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED FROM UPN-SEARCH: H749391421900 - FW EZ 3.5-5.5 190CM PV-JP - 39142-190 TO H749201001900 - MODEL-FW EZ 190 CM - 20100-190 CORRECTED FROM COMMON DEVICE NAME: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE TO TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION. CORRECTED FROM PRODUCT CODE: NTE TO NFA. CORRECTED FROM CATALOG/MODEL #39142-190 TO #20100-190. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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 MDR # 2134265-2013-01476. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A FILTER WIRE REMOVAL DIFFICULTY AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. THE 4.0 X 28MM PROMUS ELEMENT PLUS MR STENT WAS IMPLANTED PRIOR TO THE 3.5 X 5.5MM X 190CM FILTERWIRE EZ, AND DURING THE FILTERWIRE REMOVAL, THE FILTERWIRE, IN A DEPLOYED STATE, CAUGHT ON THE STENT AND BENT THE PROXIMAL EDGE. THE FILTERWIRE WAS REMOVED AND ANOTHER UNSPECIFIED PROMUS ELEMENT STENT WAS DEPLOYED TO ADDRESS THE STENT DAMAGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR# 2134265-2013-01476. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A FILTER WIRE REMOVAL DIFFICULTY AND STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A SAPPHENOUS VEIN GRAFT TO THE RIGHT CORONARY ARTERY. THE 4.0 X 28MM PROMUS ELEMENT PLUS MR STENT WAS IMPLANTED PRIOR TO THE 3.5 X 5.5MM X 190CM FILTERWIRE EZ, AND DURING THE FILTERWIRE REMOVAL, THE FILTERWIRE, IN A DEPLOYED STATE, CAUGHT ON THE STENT AND BENT THE PROXIMAL EDGE. THE FILTERWIRE WAS REMOVED AND ANOTHER UNSPECIFIED PROMUS ELEMENT STENT WAS DEPLOYED TO ADDRESS THE STENT DAMAGE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107700 FILTERWIRE EZ¿ TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201001900

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention