BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 2083348 · Received May 10, 2011

    Report

    Report Number
    2134265-2011-01651
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT - 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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 RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, A VESSEL DISSECTION OCCURRED. A CLOT WAS NOTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) BEFORE TREATMENT, SO A FILTERWIREEZ WAS USED TO PREVENT EMBOLUS. THE PHYSICIAN NOTED THAT THE FILTERWIRE EZ MAY HAVE CAUSED A VESSEL DISSECTION IN THE DISTAL SFA, BUT HE WAS NOT SURE. A NON BSC STENT DID NOT ADVANCE WELL OVER THE .014 FILTER-WIRE. PRE-DILATION WAS ALSO PERFORMED 2-3 TIMES. IT WAS NOTED THAT THERE WERE A LOT OF DEVICES PUT IN AND OUT OVER THE FILTER-WIRE AND THE PHYSICIAN THINKS IT MAY HAVE MOVED THE FILTER-WIRE BACK AND FORTH A BIT. AFTER THE PROCEDURE AND REMOVAL OF FLITERWIRE EZ THERE WAS A CLOT IN THE PERONEAL WHICH WAS TREATED WITH ANGIOPLASTY AND "THE THROMBUS AND HAD OK RUN OFF". THE DISSECTION WAS ALSO TREATED WITH ANGIOPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    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 13381429

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VIABAHN STENT