BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MO.MA ULTRA

    MDR report key: 3062514 · Received April 17, 2013

    Report

    Report Number
    3004066202-2013-00055
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    February 20, 2013
    Report Date
    August 11, 2015
    Manufacturer
    INVATEC SPA
    Product Code
    NTE
    PMA / PMN Number
    K092177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT). CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT). CONCLUSIONS: KNOWN INHERENT RISK OF PROCEDURE (CEREBROVASCULAR ACCIDENT).

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SYMPTOMATIC WITH A MINOR STROKE AT THE TIME OF THE INDEX PROCEDURE. THE CEA RISK FACTOR WAS A CONTRALATERAL CAROTID ARTERY LESION. THE MO MA ULTRA BALLOON WAS USED TO TREAT THE RIGHT ICA WHICH EXHIBITED 95% STENOSIS, TYPE II AORTA.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED ONE MO.MA ULTRA BALLOON DURING CAROTID ARTERY STENTING. IT IS REPORTED THAT THE MO.MA WAS SUCCESSFULLY IMPLEMENTED HOWEVER, LATER THAT DAY FOLLOWING THE INDEX PROCEDURE, SUBARACHNOID BLEEDING WAS OBSERVED. IT WAS TREATED WITH COIL EMBOLIZATION. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE BUT WAS RELATED TO THE PROCEDURE. THE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164414 MO.MA ULTRA CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE NTE INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention