BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1932858 · Received December 20, 2010

    Report

    Report Number
    2134265-2010-05567
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT LOST CONSCIOUSNESS AND EXPERIENCED A STROKE. THE GREATER THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT COMMON CAROTID ARTERY. THIS 8.0-29 CAROTID WALLSTENT WAS IMPLANTED IN THE LESION SUCCESSFULLY WITHOUT COMPLICATIONS RESULTING IN LESS THAN 30% RESIDUAL STENOSIS. THE PATIENT WAS GIVEN ANTICOAGULANT/ANTIPLATELETS BEFORE AND DURING THE PROCEDURE. THE PATIENT WAS KEPT FOR OBSERVATION. FOR THE FIRST HOUR AFTER THE PROCEDURE, THE PATIENT WAS ABLE TO ANSWER QUESTIONS. AFTER A FEW HOURS, THE PATIENT SHOWED "EXTRAORDINARY SYMPTOMS" INCLUDING LOSS OF CONSCIOUSNESS. THE PHYSICIAN SENT THE PATIENT FOR AN ANGIOGRAM WHERE A BLOOD CLOT WAS OBSERVED IN THE RIGHT SIDE OF THE BRAIN. 12 HOURS POST PROCEDURE, A CEREBRAL HEMORRHAGE OCCURRED AND THE PATIENT WAS TAKEN TO SURGERY. THE SURGERY WAS SUCCESSFUL, HOWEVER, THE PATIENT REMAINS UNCONSCIOUS ON LIFE SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647080 12119952

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R FILTERWIRE