BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    MDR report key: 4848399 · Received June 16, 2015

    Report

    Report Number
    2134265-2015-03603
    Event Type
    Injury
    Date Received
    June 16, 2015
    Report Date
    May 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CSOBAY-NOVAK , CSABA ET. AL. (2015) "ROLE OF STENT SELECTION IN THE INCIDENCE OF PERSISTING HEMODYNAMIC DEPRESSION AFTER CAROTID ARTERY STENTING" JOURNAL OF ENDOVASCULAR THERAPY, VOL. 22(I) 122-129. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 VIA JOURNAL ARTICLE THAT PATIENT COMPLICATION OF ASYSTOLE WAS REPORTED DURING PROCEDURE. TEMPORARY PACEMAKER REQUIRED THAT WAS CONVERTED TO A PERMANENT PACEMAKER DEVICE 24 HOURS AFTER DRUG WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390610 FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION NFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK524

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention