BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROTHESIS

    MDR report key: 1899218 · Received November 15, 2010

    Report

    Report Number
    2134265-2010-05194
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 FURTHER REPORTED THAT THE PHYSICIAN NOTED THE LOW BLOOD PRESSURE OF 60/42MM HG IMMEDIATELY AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-05310. CAROTID WALLSTENT / FILTERWIRE EZ (B)(6) STUDY. IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED HYPOTENSION. THE INDEX PROCEDURE TREATED THE LEFT COMMON CAROTID / INTERNAL CAROTID ARTERY WITH PLACEMENT OF A FILTERWIRE EZ AND A 8.0X21MM CAROTID WALLSTENT. FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED LOW BLOOD PRESSURE. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H749391508210 13354949

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other FILTERWIRE EZ