BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1874303 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04743
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    March 2, 2010
    Report Date
    September 23, 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: AS THE DEVICE HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE MOST PROBABLE 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). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED HYPOTENSION. THE TARGET LESION WAS LOCATED IN THE RIGHT OSTIUM INTERNAL CAROTID ARTERY, THAT WAS 8MM LONG WITH AN 8MM REFERENCE DIAMETER AND 83% STENOSIS. THE TARGET LESION WAS TREATED WITH A FILTERWIRE EZ AND PLACEMENT OF A CAROTID WALLSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 5%. THE FOLLOWING DAY PRE-DISCHARGE, THE PATIENT HAD TRANSIENT HYPOTENSION WITH THE BLOOD PRESSURE REPORTED AS 83/36. THERE WAS NO TREATMENT GIVEN AND IT IS STATED THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY M001719040 12985279

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other FILTERWIRE EZ