BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1812344 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03730
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    June 17, 2009
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    NFA
    PMA / PMN Number
    K061332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A VAGAL RESPONSE INSTEAD OF BRADYCARDIA AND HYPOTENSION.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS 2134265-2010-03683. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED HYPOTENSION WITH INTERMITTENT BRADYCARDIA. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY WITH 84% STENOSIS, A LENGTH OF 26 MM, AND A REFERENCE VESSEL DIAMETER OF 3.7MM. THE PHYSICIAN TREATED THE LESION WITH A FILTERWIRE EZ AND PLACEMENT OF A CAROTID WALLSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 5%. THE NEXT DAY THE PATIENT EXPERIENCED HYPOTENSION WITH INTERMITTENT BRADYCARDIA. THE EVENT CAUSED THE PATIENT'S INDEX HOSPITALIZATION TO BE PROLONGED. THE PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE WITH THE EVENT LISTED AS RESOLVED.

    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 H749201003000 0000833603

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization CAROTID WALLSTENT