BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAROTID WALLSTENT MONORAIL

    MDR report key: 1812426 · Received August 24, 2010

    Report

    Report Number
    2134265-2010-03780
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 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

    SAME CASE AS MFR REPORT #: 2134265-2010-03752. IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE FILTERWIRE EZ BASKET TORE WHILE INSIDE OF THE PATIENT. THE STENTING PROCEDURE TREATED THE 99% STENOSED TARGET LESION LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY. TREATMENT UTILIZED PRE-DILATION WITH A 4.0X30MM MAVERICK BALLOON INFLATED TO 8 ATM'S, A BSC FILTERWIRE EZ AND THE PLACEMENT OF A 10X31MM CAROTID WALLSTENT WITH NO ISSUE. RESISTANCE WAS MET UPON WITHDRAWAL OF THE FILTERWIRE EZ DUE TO THE EMBOLIC PLAQUE MATERIAL CAUGHT IN THE FILTER BASKET, AND IT WAS NOT POSSIBLE TO COMPLETELY PULL THE FILTERWIRE EZ BACK INTO THE SHEATH. THE PATIENT EXPERIENCED AN ANTEROGRADE FLOW OCCLUSION. THE PHYSICIAN MADE A DECISION TO WITHDRAW THE FILTERWIRE IN AN "OPEN" STATE AND THE BOTTOM OF THE FILTER BASKET TORE AND GOT CAUGHT ON THE PROXIMAL PORTION OF THE PREVIOUSLY PLACED CAROTID WALLSTENT, LEAVING APPROXIMATELY 20% OF THE BASKET BEHIND. A SECOND FILTERWIRE EZ WAS PLACED TO PROTECT THE VESSEL FROM MIGRATION OF THE TORN BASKET. A 8X21MM CAROTID WALLSTENT WAS THEN PLACED AT THE TARGET LESION TO TRAP THE ENTIRE PORTION OF THE DETACHED FILTER BASKET AGAINST THE ARTERIAL WALL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID WALLSTENT MONORAIL STENT, CAROTID NIM BOSTON SCIENTIFIC - GALWAY H965SCH647130 13023441

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention FILTERWIRE EZ| 4.0X30MM MAVERICK BALLOON| GUIDER XF 40 8FR GUIDE CATHETER