BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL ENDOPROTHESIS

    MDR report key: 1813516 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03792
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS A LONG, TOTALLY OCCLUDED LESION. PRIOR TO THE STUDY CAROTID WALLSTENT PLACED, ANOTHER MANUFACTURER'S STENT WAS ALSO PLACED IN THE LESION. THE IN-STENT RESTENOSIS WAS NOTED TO BE LOCATED WITHIN THE CAROTID WALLSTENT PORTION OF THE VESSEL.

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED LOW BLOOD PRESSURE, TRANSIENT ISCHEMIC ATTACK (TIA), AND IN-STENT RESTENOSIS. THE INDEX PROCEDURE TREATED THE RIGHT COMMON CAROTID AND INTERNAL CAROTID ARTERY. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. A FILTERWIRE EZ WAS PLACED. THE LESION WAS PREDILATED, A 10.0X31MM CAROTID WALLSTENT WAS PLACED, AND POST DILATION WAS PERFORMED RESULTING IN 0% RESIDUAL STENOSIS. DURING THE IMPLANT PROCEDURE, THROMBUS ASPIRATION WAS ALSO PERFORMED. THE SAME DAY AS THE INDEX PROCEDURE, THE PATIENT EXPERIENCED LOW BLOOD PRESSURE WHICH WAS TREATED WITH A VASOPRESSOR RESULTING IN AN "IMPROVED" OUTCOME TWO DAYS POST PROCEDURE. NINE DAYS POST PROCEDURE A TIA OCCURRED. TWO DAYS LATER IN-STENT RESTENOSIS OCCURRED. THE TIA AND IN-STENT RESTENOSIS WERE TREATED MEDICALLY. HOWEVER, POST-TIA THE PATIENT'S CONDITION WAS IMPROVED AND POST IN-STENT RESTENOSIS IT WAS UNCHANGED AFTER 30 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL ENDOPROTHESIS STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H7493915010310 13358621

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention