BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1812404 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03752
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: PER THE PRODUCT ANALYSIS, THE FILTER BAG WAS RETRACTED FULLY INTO THE RETRIEVAL SHEATH. WITH 5MM OF THE NOSECONE EXPOSED OUT OF THE DISTAL TIP OF THE RETRIEVAL SHEATH, THE PROTECTION WIRE WAS BENT, THE DISTAL TIP OF THE PROTECTION WIRE WAS BENT AND WAS STRETCHED. UNSHEATHING TESTING WAS PERFORMED WITH NO DIFFICULTY AND THE DISTAL TIP OF THE FILTER WAS DAMAGED AND HAD A HOLE IN IT. 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

    SAME CASE AS MFR REPORT #: 2134265-2010-03780. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE FILTERWIRE EZ BASKET TORE WHILE INSIDE OF THE PATIENT. THE STENTING PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. TREATMENT UTILIZED PRE-DILATION WITH A 4.0X30MM MAVERICK BALLOON INFLATED TO 8 ATM'S, A BSC FILTERWIRE EZ AND THE PLACEMENT OF A 10X31MM CAROTID WALLSTENT WITH NO ISSUE. RESISTANCE WAS MET UPON WITHDRAWAL OF THE FILTERWIRE EZ DUE TO THE EMBOLIC PLAQUE MATERIAL CAUGHT IN THE FILTER BASKET, AND IT WAS NOT POSSIBLE TO COMPLETELY PULL THE FILTERWIRE EZ BACK INTO THE SHEATH. THE PATIENT EXPERIENCED AN ANTEROGRADE FLOW OCCLUSION. THE PHYSICIAN MADE A DECISION TO WITHDRAW THE FILTERWIRE IN AN "OPEN" STATE AND THE BOTTOM OF THE FILTER BASKET TORE AND GOT CAUGHT ON THE PROXIMAL PORTION OF THE PREVIOUSLY PLACED CAROTID WALLSTENT, LEAVING APPROXIMATELY 20% OF THE BASKET BEHIND. A SECOND FILTERWIRE EZ WAS PLACED TO PROTECT THE VESSEL FROM MIGRATION OF THE TORN BASKET. A 8X21MM CAROTID WALLSTENT WAS THEN PLACED AT THE TARGET LESION TO TRAP THE ENTIRE PORTION OF THE DETACHED FILTER BASKET AGAINST THE ARTERIAL WALL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    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 H749201051900 0000901911

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention 4.0X30MM MAVERICK BALLOON| GUIDERXF 40 8FR GUIDE CATHETER| 10X31 CAROTID WALLSTENT