BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA. ULTRA 6F ID

    MDR report key: 3203684 · Received July 3, 2013

    Report

    Report Number
    3004066202-2013-00105
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    April 6, 2013
    Report Date
    September 22, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: PATIENT'S CONDITION - PREDISPOSED EVENT (HISTORY OF STROKE, HIGH BLOOD PRESSURE, AGE). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE TO EVENT DATE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PATIENT WAS SUCCESSFULLY TREATED WITH A MO.MA ULTRA CEREBRAL PROTECTION DEVICE AND AN UNKNOWN BRAND STENT TO THE RIGHT ICA-CCA. INTOLERANCE WAS NOTED DURING THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS REPORTED TO HAVE SUFFERED HYPER PERFUSION SYNDROME. THE PATIENT WAS CONTROLLED BY GENERAL ANAESTHESIA FOR 1 WEEK AND BY ARTIFICIAL RESPIRATION FOR 2 WEEKS. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR REHABILITATION. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR THE PROCEDURE. OUTCOME OF THE EVENT IS REPORTED AS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305349 MO.MA. ULTRA 6F ID CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention