BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 4232656 · Received November 6, 2014

    Report

    Report Number
    2134265-2014-06655
    Event Type
    Death
    Date Received
    November 6, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIM
    PMA / PMN Number
    P050019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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. LITERATURE CITATION: JIMENEZ-GOMEZ, E. (2014). UNPROTECTED CAROTID ARTERY STENTING IN SYMPTOMATIC ELDERLY PATIENTS: A SINGLE-CENTER EXPERIENCE. JOURNAL OF NEUROINTERVENTIONAL SURGERY, 0:1-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE THAT PATIENT DEATH OCCURRED. PATIENTS WERE TREATED WITH CAROTID WALLSTENTS AND OTHER NON-BSC STENTS. DEATH OCCURRED IN THREE CASES: ONE AT 30 DAYS DUE TO STROKE OR HEMORRHAGE AND TWO NON-RELATED (ONE DUE TO NOSOCOMIAL PNEUMONIA AND ONE DUE TO INTESTINAL ISCHEMIA) AT 30 DAYS. IT IS UNCLEAR IF BSC STENTS WERE USED IN EACH OF THE PATIENTS THAT LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713149 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY UNK60

    Patients

    Seq Age Sex Outcome Treatment
    1 Death