BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1822993 · Received September 1, 2010

    Report

    Report Number
    2134265-2010-03940
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    March 1, 2010
    Report Date
    August 5, 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

    PATIENT IDENTIFIER: (B)(6). 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. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(6). SAME CASE AS MFR REPORT #: 2134265-2010-03940. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED HYPOTENSION. THE INDEX PROCEDURE TREATED THE 84% STENOSED, 5X10MM TARGET LESION LOCATED IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. TREATMENT UTILIZED A BSC FILTERWIRE EZ AND PLACED A 8X21MM CAROTID WALLSTENT. FOLLOWING POST DILATION THE RESIDUAL STENOSIS WAS 0%. PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED HYPOTENSION AND WAS TREATED WITH MEDICATION. THE NEXT DAY, THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE FILTERWIRE EZ AND "PROBABLY RELATED" TO THE CAROTID WALLSTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719010 0013103680

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention FILTER WIREEZ