BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXSTENT MONORAIL

    MDR report key: 1242994 · Received November 21, 2008

    Report

    Report Number
    2134265-2008-04436
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIM
    PMA / PMN Number
    P050025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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 MANUFACTURING RECORDS FOR THIS DEVICE INDICATED THAT THE PRODUCT WAS MANUFACTURED WITH NO DISCREPANCIES. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DEVICE LABELING.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 357 DAYS AFTER CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. THE TARGET LESION WAS LOCATED IN THE RIGHT PROXIMAL INTERNAL CAROTID ARTERY, WITH 90% STENOSIS AND WAS 26 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 6.3 MM. THE PHYSICIAN TREATED THE LESION WITH PLACEMENT OF A FILTERWIRE EZ AND A 4-9 X 30 MM NEXSTENT. FOLLOWING POST-DILATATION, THERE WAS 29% RESIDUAL STENOSIS. NIH STROKE SCALE PERFORMED THE NEXT DAY WAS 0. THE PATIENT WAS SEEN FOR A 12-MONTH FOLLOW-UP VISIT. A PHYSICAL EXAMINATION SHOWED THE PATIENT DID NOT HAVE ANY PROBLEMS RELATIVE TO HIS CAROTID ARTERY DISEASE. THE PATIENT DID NOT HAVE PROBLEM ASSOCIATED WITH HIS DIABETES AND NEUROPATHY. FOLLOW-UP CAROTID DUPLEX REVEALED RESTENOSIS. THE SITE REPORTED THAT THERE WAS NO TREATMENT DONE FOR THE STENOSIS. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE RESTENOSIS TO THE NEXSTENT IS PROBABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXSTENT MONORAIL NIM STENT, CAROTID NIM BOSTON SCIENTIFIC NA C71302

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O