BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRO ELITE SNARE

    MDR report key: 1144226 · Received August 29, 2008

    Report

    Report Number
    1225894-2008-00003
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    RADIUS MEDICAL TECHNOLOGIES, INC.
    Product Code
    MMX
    PMA / PMN Number
    071457
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: DEVICE DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: INTERVENTION TO REMOVE DETACHED SNARE. IT WAS REPORTED THAT POST NON-ABBOTT STENT IMPLANTATION IN THE RIGHT INTERNAL CAROTID ARTERY, DURING REMOVAL OF A NON-ABBOTT FILTER, THE FILTER SEPARATED FROM THE GUIDE WIRE AND REMAINED IN THE CAROTID ARTERY. THE FILTER COULD NOT BE RETRIEVED USING AN AMPLATZ GOOSENECK SNARE. FILTER RETRIEVAL WAS ATTEMPTED USING THE EXPRO ELITE; HOWEVER, DURING ADVANCEMENT IN THE CAROTID ARTERY, THE EXPRO ELITE SNARE BECAME STUCK AND DETACHED INTO TWO PIECES. A PORTION OF THE SNARE WAS REMOVED AND A PORTION REMAINED IN THE VESSEL. AT THIS TIME A DISSECTION WAS OBSERVED IN THE VESSEL. A NON-ABBOTT STENT WAS IMPLANTED TO TREAT THE DISSECTION. THE DETACHED PORTION OF THE EXPRO ELITE AND THE FILTER WERE RETRIEVED FROM THE BODY USING ANOTHER GOOSENECK SNARE. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRO ELITE SNARE MMX RADIUS MEDICAL TECHNOLOGIES, INC. NA 07W14259

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention AMPLATZ GOOSENECK SNARE| 6.0 SPIDER EMBOLIC PROTECTION DEVICE| PROTEGE STENT