BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    MDR report key: 1040027 · Received May 7, 2008

    Report

    Report Number
    9616695-2008-00065
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 16, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ABBOTT VASCULAR GALWAY
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DIFFICULT REMOVAL, DEVICE BREAKAGE. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: STROKE, PORTION OF FILTER SYSTEM REMAINS IN VASCULATURE. IT WAS REPORTED THAT DURING A RIGHT INTERNAL CAROTID ARTERY STENTING PROCEDURE, A PORTION OF THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (EPS) DETACHED DURING EPS RETRIEVAL AND REMAINS IN THE MIDDLE CEREBRAL ARTERY. FOLLOWING RIGHT INTERNAL CAROTID ARTERY STENT PLACEMENT SOME RESISTANCE WAS FELT WHEN THE EPS WAS PULLED THROUGH THE STENT. AFTER REMOVAL, IT WAS FOUND THAT THE POLYURETHANE SHEATH AND DISTAL MARKER WERE STRIPPED OFF AND REMAINED IN THE VESSEL. EXTENSIVE PERCUTANEOUS TRANSLUMINAL ATTEMPTS TO RETRIEVE THE EPS MATERIAL WERE NOT SUCCESSFUL AND DURING THE RETRIEVAL ATTEMPT, THE PATIENT EXPERIENCED VASOSPASM, TREATED WITH NITROGLYCERIN. THE RETRIEVAL PROCEDURE WAS ABANDONED AND THE PATIENT WAS PLACED ON PLAVIX FOR ANTICOAGULATION. POST-OPERATIVELY, THE PATIENT WAS FOUND TO HAVE A RIGHT TEMPOROPARIETAL STROKE WITH HEMORRHAGIC CONVERSION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOSHIELD EMBOLIC PROTECTION SYSTEM NTE ABBOTT VASCULAR GALWAY NA 475161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| S XACT STENT