BEUDAMED
    FDA Adverse Event Summary report: N

    GUARDWIRE 200CM W/6F EXPORT XT

    MDR report key: 2363610 · Received December 8, 2011

    Report

    Report Number
    1220452-2011-00082
    Date Received
    December 8, 2011
    Date of Event
    July 4, 2011
    Report Date
    December 21, 2011
    Manufacturer
    MEDTORNIC, INC
    Product Code
    NFA
    PMA / PMN Number
    K023878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS UNKNOWN AND THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CAN NOT BE PERFORMED. THE EVENT IS NOT CONFIRMED DUE TO NO PRODUCT RETURNED. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THEREFORE AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS UNKNOWN AND THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD CAN NOT BE PERFORMED. IF IN THE FUTURE THE ACTUAL SAMPLE OR ADDITIONAL INFORMATION IS PROVIDED A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION. (B)(4) - THE EVENT HAS NOT BEEN CONFIRMED DUE TO NO PRODUCT RETURNED. THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADVERSE EVENT INFORMATION FROM PMS (POST MARKETING SURVEILLANCE) PATIENT : (B)(6), MALE (B)(6) 2011 (OPERATION DATE): CAS OPERATION WAS PERFORMED TO L-ICA USING RELEVANT DEVICE FOR DISTAL PROTECTION. ASYMPTOMATIC CEREBRAL INFARCTION(CONFIRMED ON MRI) AND HYPERPERFUSION SYNDROME WAS OBSERVED AFTER THE OPERATION. (B)(6) 2011: 30 DAYS FOLLOW-UP WAS PERFORMED. PHYSICIAN ASSESSED THESE 2 EVENTS WERE NOT ADVERSE EVENT. NOTE:PHYSICIAN DENIED THE RELATIONSHIP BETWEEN THE RELEVANT DEVICE AND 2 EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE 200CM W/6F EXPORT XT DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC NFA MEDTORNIC, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention