BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1873765 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04756
    Event Type
    Injury
    Date Received
    October 19, 2010
    Report Date
    September 22, 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

    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. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY TREATMENT PROCEDURE THE PATIENT EXPERIENCED WORSENING OF THE STROKE SCALE. THE LESION BEING TREATED IS UNKNOWN. THE PHYSICIAN SUCCESSFULLY IMPLANTED A CAROTID WALLSTENT OF UNKNOWN SIZE. IT WAS REPORTED THAT THE MODIFIED RANKIN SCALE (MRS) ASSESSMENT PRIOR TO THE PROCEDURE WAS 0 AND 30 DAYS POST PROCEDURE THE MRS ASSESSMENT WAS 1. IT IS UNKNOWN IF THERE WAS FURTHER TREATMENT AND THE PATIENTS CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN NOW REPORTED THERE WAS NO WORSENING OF MRS GRADE. THIS WAS REPORTED IN ERROR. THERE WAS NO ADVERSE EVENT AND THE PATIENT CONDITION IS FINE. THE CORRECT MRS GRADE IS: PRE-PROCEDURE: GRADE 0 => POST-30 DAYS: GRADE 0 NOT 1 AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY UNK60

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other