BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1413231 · Received July 10, 2009

    Report

    Report Number
    2134265-2009-03272
    Event Type
    Injury
    Date Received
    July 10, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 12, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2009-03271, -03270. CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, THE STENT MIGRATED AND THE PATIENT EXPERIENCED PAIN POST PROCEDURE. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 7.9X15MM LESION OF THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. TREATMENT CONSISTED OF PLACEMENT OF A FILTERWIRE EZ AND PLACEMENT OF A 10X24MM CAROTID WALLSTENT. THE 10X24MM STENT DEPLOYED SUCCESSFULLY, BUT THE STENT MIGRATED FROM THE INTENDED LOCATION. A SECOND 10X31MM CAROTID WALLSTENT WAS PLACED TO COVER THE LESION AND POST DILATION WAS PERFORMED RESULTING IN 2% RESIDUAL STENOSIS. POST PROCEDURE, THE PATIENT EXPERIENCED NECK AND JAW PAIN. THE PATIENT WAS TREATED WITH MORPHINE AND THE EVENT WAS RESOLVED. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE. THE INVESTIGATOR ASSESSED THE PATIENT'S PAIN AS POSSIBLY RELATED TO THE FILTERWIRE EZ AND HIGHLY PROBABLE TO THE CAROTID WALLSTENTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED, THE PATIENT ALSO EXPERIENCED AN EVENT OF TRANSIENT HYPOTENSION ON THE DAY OF THE INDEX PROCEDURE. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT RESOLVED THE SAME DAY. THE INVESTIGATOR ASSESSED THE HYPOTENSION EVENT AS POSSIBLY RELATED TO THE CAROTID WALLSTENTS AND UNRELATED TO THE FILTERWIRE EZ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC CORPORATION M001719050 12106010

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention