BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROTHESIS

    MDR report key: 1901191 · Received November 17, 2010

    Report

    Report Number
    2134265-2010-05164
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    September 9, 2010
    Report Date
    October 22, 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 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 FURTHER REPORTED THE INDEX PROCEDURE WAS RIGHT BRACHIAL APPROACH. PRE AND POST DILATATION WERE PERFORMED. STENOSIS POST PROCEDURE WAS 24%. THE FILTER WIRE WAS NOT USED. ANOTHER DISTAL PROTECTION DEVICE WAS USED.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05173. (B)(4). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA. IN (B)(6) 2010, THE INDEX PROCEDURE TREATED AN UNKNOWN LESION WITH PLACEMENT OF A FILTERWIRE EZ AND A 8.0X21MM CAROTID WALLSTENT. WITH IN 24 HOURS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED BRADYCARDIA AND LOW BLOOD PRESSURE, 108/62MM/HG. THE PATIENT WAS TREATED WITH MEDICATION (VASOPRESSOR) AND THE EVENT WAS RESOLVED. THE EVENT WAS RESOLVED 2 DAYS LATER. ACCORDING TO THE PHYSICIAN THIS WAS RELATED TO THE WALLSTENT BY THE STENT SELF-EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H749391508210 13359584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention