BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIEN INTRACRANIAL CATHETER

    MDR report key: 6728185 · Received July 20, 2017

    Report

    Report Number
    2029214-2017-00911
    Event Type
    Injury
    Date Received
    July 20, 2017
    Date of Event
    June 24, 2016
    Report Date
    July 6, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    DQY
    PMA / PMN Number
    K110055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: H JANSSEN, M KILLER-OBERPFALZER, M PATZIG, G BUCHHOLZ, J LUTZ. ULTRA-DISTAL ACCESS OF THE M1 SEGMENT WITH THE 5FR NAVIEN DISTAL ACCESS CATHETER IN ACUTE (ANTERIOR CIRCULATION) STROKE: IS IT SAFE AND EFFICIENT? J NEUROINTERVENT SURG 2017;9:650¿653. DOI :10.1136/NEURINTSURG-2016-012370. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND SUCCESS RATE OF ULTRA-DISTAL ACCESS OF THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT WITH THE 5FR NAVIEN 58 DISTAL ACCESS CATHETER IN THE TREATMENT OF ACUTE STROKE IN COMBINATION WITH STENT RETRIEVERS. THIS WAS A RETROSPECTIVE REVIEW OF 81 PATIENTS (43 WOMEN; MEAN AGE 71.3 AND 38 MEN MEAN AGE OF 66.4). THE NAVIEN DISTAL ACCESS CATHETERS WILL NOT RETURN FOR EVALUATION AS THESE EVENTS WERE DISCOVERED VIA LITERATURE REVIEW; THEREFORE, PRODUCT ANALYSIS OF THE CATHETERS WAS NOT ABLE TO BE PERFORMED. THE VASOSPASM DURING THE ENDOVASCULAR PROCEDURE WAS MOST LIKELY MECHANICALLY INDUCED. IN THIS EVENT, THE VASOSPASM WAS SUCCESSFULLY TREATED WITH NIMODIPINE. VASOSPASM IS A KNOWN INHERENT RISK OF ENDOVASCULAR PROCEDURE AND IS DOCUMENTED IN THE NAVIEN INSTRUCTION FOR USE. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. 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

    MEDTRONIC RECEIVED INFORMATION THROUGH LITERATURE REVIEW THAT OF 81 CASES OF ULTRA-DISTAL ACCESS (UDA) OF THE MIDDLE CEREBRAL ARTERY WITH THE NAVIEN CATHETER, 3 PATIENTS EXPERIENCED VASOSPASM AFTER UDA IN THE M1 SEGMENT WHICH WAS REVERSED WITH DILUTED NIMODIPINE VIA CATHETER FLUSH (2MG IN 500ML NACL). THE PATIENTS WERE RECEIVING MECHANICAL THROMBECTOMY TO TREAT ACUTE STROKES OF THE ANTERIOR CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510096 NAVIEN INTRACRANIAL CATHETER CATHETER, PERCUTANEOUS DQY COVIDIEN (IRVINE) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention