BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILTERWIRE EZ EMOBLIC PROTECTION SYSTEM

    MDR report key: 1852544 · Received October 4, 2010

    Report

    Report Number
    2134265-2010-04565
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    June 8, 2010
    Report Date
    September 10, 2010
    Product Code
    NFA
    PMA / PMN Number
    K032884
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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

    (B)(4) SAME PATIENT AS 2134265-2010-04564. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. THE LESION BEING TREATED WAS LOCATED IN THE RIGHT COMMON CAROTID-INTERNAL CAROTID FEMORAL ARTERY. THE PHYSICIAN TREATED THE LESION WITH A FILTERWIRE EZ AND IMPLANTING A CAROTID WALLSTENT. POST PROCEDURE, THE PATIENT DEVELOPED LOW BLOOD PRESSURE. PRE-INDEX PROCEDURE: 152/80 POST-INDEX PROCEDURE: 92/44. THE PATIENT WAS TREATED WITH ATROPINE SULFATE. IN THE OPINION OF THE PHYSICIAN, THE LOW BLOOD PRESSURE WAS CAUSED BY CAROTID SINUS REFLEX AFTER STENT IMPLANT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE THE LESION BEING TREATED WAS LOCATED IN THE RIGHT COMMON CAROTID INTERNAL CAROTID ARTERY NOT THE RIGHT COMMON CAROTID-INTERNAL CAROTID FEMORAL ARTERY AS ORIGINALLY STATED.

    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 UNK523

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention CAROTID WALLSTENT