BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1786327 · Received August 5, 2010

    Report

    Report Number
    2134265-2010-03660
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    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

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2010-03659. (B)(4). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCES AND AN ELEVATED TEMPERATURE. THE INDEX PROCEDURE TREATED A 72% STENOSED LESION AT THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY MEASURING 5.0X23MM. TREATMENT CONSISTED OF PLACEMENT OF A FILTERWIRE EZ DISTAL PROTECTION WIRE, DEPLOYMENT OF AN 8X36MM CAROTID WALLSTENT, AND POST DILATION RESULTING IN 10% RESIDUAL STENOSIS. ON THE SAME DAY AS THE INDEX PROCEDURE THE PATIENT EXPERIENCED BILATERAL VISUAL DISTURBANCES. NO ACTION WAS TAKEN AND THE EVENT RESOLVED THE SAME DAY WITHOUT RESIDUAL EFFECTS. ONE DAY POST PROCEDURE THE PATIENT EXPERIENCED AN ELEVATED TEMPERATURE OF 102.4 DEGREES F. AN UNSPECIFIED MEDICATION WAS ADMINISTERED AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT ON THE DATE OF THE INDEX PROCEDURE AND PRIOR TO DISCHARGE THE PATIENT EXPERIENCED HYPOTENSION. THE EVENT RESOLVED THE SAME DAY WITHOUT RESIDUAL EFFECTS. THE INVESTIGATOR ASSESSED THE HYPOTENSION EVENT AS POSSIBLY RELATED TO THE CAROTID WALLSTENT AND THE STUDY PROCEDURE, BUT 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 - GALWAY M001719030 12462246

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention