BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ?

    MDR report key: 3063556 · Received April 17, 2013

    Report

    Report Number
    2134265-2013-02404
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE PROTECTION WIRE AND THE RETRIEVAL SHEATH WERE RETURNED. DURING THE VISUAL AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE, THE RADIOPAQUE DISTAL TIP OF THE PROTECTION WIRE WAS FOUND CURVED, WAVY, AND HAD BEEN STRETCHED APPROXIMATELY 1 CM ON ITS PROXIMAL PORTION. APPROXIMATELY 10 CM OF THE DISTAL PORTION OF THE WIRE WAS STICKING OUT OF THE RETRIEVAL SHEATH, WHEN MEASURED FROM THE DISTAL TIP OF THE PROTECTION WIRE. THE FILTER BAG WAS FOUND DEPLOYED AND IN GOOD CONDITION. BLOOD WAS FOUND ON THE INSIDE OF THE RETRIEVAL SHEATH AND INSIDE THE FILTER BAG. THE DEVICE WAS FOUND KINKED AT 35 CM, WHEN MEASURED FROM THE DISTAL END, AND THE SHEATH WAS FOUND CURVED AT THE COREWIRE. THE RETRIEVAL WAS ALSO FOUND STRETCHED AT 2 CM FROM THE DISTAL END. THE DISTAL SHEATH WAS FOUND SEPARATED INTO TWO PARTS AT THE MARKER BAND. THE SEPARATION HAD OCCURRED AT 3 MM FROM THE DISTAL END OF THE RETRIEVAL SHEATH. THE MARKER BAND WAS FOUND STILL INTACT ON THE DISTAL END OF THE SEPARATED SHEATH. IT WAS NOT LOOSE OR DETACHED. 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 REPORTED THAT DURING A TREATMENT STENTING PROCEDURE, THE MARKER BAND DETACHED. THE LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. THE FILTERWIRE EZ WAS OPENED IN THE ARTERY. NO PREDILATION WAS PERFORMED. A NON BSC STENT WAS ADVANCED NEAR THE STENOSIS. PRIOR TO STENT DEPLOYMENT IT WAS NOTICED THAT THE FILETRWIRE MOVED DOWN. THE STENT WAS REMOVED; THE FILTER WAS RECAPTURED AND REPOSITIONED. THE STENT WAS RE-INSERTED AND IMPLANTED. THE ANGIOGRAPHY IMAGES REVEALED A MARKER IN THE LUMEN BETWEEN THE FILTER AND THE STENT. THE FILTER WAS CAPTURED WITH A GUIDE CATHETER TO ALSO CAPTURE THE MARKER. THE MARKER WAS THE DISTAL TIP OF THE BLUE RECOVER SHEATH OF FILTERWIRE WHICH SEPARATED FROM THE BODY OF THE SHEATH. THE PATIENT REMAINED STABLE AND NO FURTHER COMPLICATION HAS BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT STENTING PROCEDURE, THE MARKER BAND DETACHED. THE LESION WAS LOCATED IN THE INTERNAL CAROTID ARTERY. THE FILTERWIRE EZ WAS OPENED IN THE ARTERY. NO PREDILATION WAS PERFORMED. A NON BSC STENT WAS ADVANCED NEAR THE STENOSIS. PRIOR TO STENT DEPLOYMENT IT WAS NOTICED THAT THE FILETRWIRE MOVED DOWN. THE STENT WAS REMOVED; THE FILTER WAS RECAPTURED AND REPOSITIONED. THE STENT WAS RE-INSERTED AND IMPLANTED. THE ANGIOGRAPHY IMAGES REVEALED A MARKER IN THE LUMEN BETWEEN THE FILTER AND THE STENT. THE FILTER WAS CAPTURED WITH A GUIDE CATHETER TO ALSO CAPTURE THE MARKER. THE MARKER WAS THE DISTAL TIP OF THE BLUE RECOVER SHEATH OF FILTERWIRE WHICH SEPARATED FROM THE BODY OF THE SHEATH. THE PATIENT REMAINED STABLE AND NO FURTHER COMPLICATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166024 FILTERWIRE EZ? TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - SAN JOSE H749201051900 15492937

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention