BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBOSHIELD EMBOLIC PROTECTION SYSTEM

    MDR report key: 1013850 · Received March 14, 2008

    Report

    Report Number
    9616695-2008-00025
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    December 1, 2006
    Report Date
    February 21, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A RETROSPECTIVE STUDY NOTED IN AN ARTICLE. NO DEVICES WERE AVAILABLE FOR ANALYSIS. ATTACHMENT: BAE JU KNOWN, MD; MOON HEE HAN MD; HYUN-SEUNG KANG, MD; AND CHEOLKYU JUNG, MD; "PROTECTION FILTER-RELATED EVENTS IN EXTRACRANIAL CAROTID ARTERY STENTING: A SINGLE-CENTER EXPERIENCE" JOURNAL OF ENDOVASCULAR THERAPY DECEMBER 2006; 13: 711-722.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: ENTANGLEMENT WITH STENT DELIVERY CATHETER TIP. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. THE FOLLOWING WAS NOTED DURING ARTICLE REVIEW. A RETROSPECTIVE STUDY WAS CONDUCTED OF 77 CAROTID ARTERY STENTING PROCEDURES USING TWO TYPES OF EMBOLIC PROTECTION DEVICES (EPD) TO REPORT THE COMPLICATIONS, RESCUE PROCEDURES AND CONSEQUENCES RELATED TO THE USE OF AN EMBOLIC PROTECTION FILTER DURING CAROTID ARTERY STENTING (CAS). IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING PROCEDURE, THE FILTER BECAME ENTANGLED WITHIN THE STENT DELIVERY CATHETER TIP. THE FILTER WAS SUCCESSFULLY SEPARATED FROM THE CATHETER TIP BY PULLING IT FROM THE STENTED SEGMENT. NO NEUROLOGICAL CHANGES OCCURRED. NO ABBOTT STENT DEVICES WERE USED FOR THIS STUDY AND IT WAS NOT SPECIFIED WHICH COMPETITOR STENT WAS USED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFO AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR CLOPIDOGREL| 0.014 GUIDEWIRE, SHUTTLE-SL FLEXOR,| 7 ZILVER COOK| ASPIRIN| HEPARIN| COOK.STENTS: 2 BOSTON SCI WALLSTENT| 68 CORDIS PRECISE/SMART CONTROL,