BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1829622 · Received September 9, 2010

    Report

    Report Number
    2134265-2010-03925
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    SAME CASE AS MFR REPORT #: 2134265-2010-04050. (B)(4) CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE STENT DEPLOYMENT DIFFICULTIES AND HYPOTENSION OCCURRED. THE INDEX PROCEDURE TREATED AN 80% STENOSED, 4.0X40MM LESION OF THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. TREATMENT CONSISTED OF PLACEMENT OF A FILTERWIRE EZ AND PLACEMENT OF AN 8X29MM CAROTID WALLSTENT. THE CAROTID WALLSTENT MIGRATED DISTALLY REQUIRING PLACEMENT OF A SECOND 8X29MM CAROTID WALLSTENT. FOLLOWING POST DILATION RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY AS THE PROCEDURE AND PRIOR TO DISCHARGE, THE PATIENT ALSO EXPERIENCED HYPOTENSION. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE. THE INVESTIGATOR ASSESSED THE HYPOTENSION AS POSSIBLY RELATED TO THE CAROTID WALLSTENT STUDY DEVICES 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 - GALWAY M001719020 12585396

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention FILTERWIRE EZ| 8X29MM CAROTID WALLSTENT