BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIEN INTRACRANIAL CATHETER

    MDR report key: 6454466 · Received April 3, 2017

    Report

    Report Number
    2029214-2017-00347
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    June 24, 2016
    Report Date
    March 8, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    DQY
    PMA / PMN Number
    D141002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NAVIEN CATHETERS WERE NOT RETURNED FOR EVALUATION; NO PRODUCT ANALYSIS CAN BE PERFORMED. THE VASOSPASM DURING THE ENDOVASCULAR PROCEDURES WAS MOST LIKELY MECHANICALLY INDUCED. VASOSPASM, OR CONTRACTION OF SMOOTH MUSCLE FIBERS IN THE WALL OF A VESSEL, IS A COMMONLY RECOGNIZED ADVERSE EVENT THAT MAY COMPLICATE AN ENDOVASCULAR TREATMENT BY LIMITING DISTAL BLOOD FLOW. IN THESE CASES, THE VASOSPASM WAS SUCCESSFULLY TREATED WITH NIMODIPINE. VASOSPASM IS A KNOWN INHERENT RISK OF ENDOVASCULAR TREATMENT AND IS DOCUMENTED IN THE NAVIEN INSTRUCTIONS FOR USE. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE VASOSPASM WAS DUE TO A DEVICE DEFECT, 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 LITERATURE REVIEW FOUND REPORTS OF INTRAPROCEDURAL NAVIEN-RELATED VASOSPASM. THE PURPOSE OF THIS ARTICLE WAS TO EVALUATE THE SAFETY AND SUCCESS RATE OF ULTRA-DISTAL ACCESS (UDA) OF THE MIDDLE CEREBRAL ARTERY (MCA) M1 SEGMENT WITH THE NAVIEN (5FR, 58, 125 CM) CATHETER IN THE TREATMENT OF ACUTE STROKE IN COMBINATION WITH STENT RETRIEVERS. THE AUTHORS REVIEWED 81 PATIENTS (43 WOMEN, 38 MEN, MEAN AGE OF 66.4 YEARS) WHO UNDERWENT MECHANICAL THROMBECTOMY. THE ARTICLE STATES THAT IN THREE CASES, VASOSPASM OCCURRED AFTER THE NAVIEN GAINED ULTRA-DISTAL ACCESS IN THE M1 SEGMENT. THE VASOSPASM WAS REVERSIBLE UNDER DILUTED NIMODIPINE APPLICATION VIA CATHETER FLUSH (2 MG IN 500 ML NACL). JANSSEN H, KILLER-OBERPFALZER M, PATZIG M, ET AL ULTRA-DISTAL ACCESS OF THE M1 SEGMENT WITH THE 5 FR NAVIEN DISTAL ACCESS CATHETER IN ACUTE (ANTERIOR CIRCULATION) STROKE: IS IT SAFE AND EFFICIENT? JOURNAL OF NEUROINTERVENTIONAL SURGERY PUBLISHED ONLINE FIRST: 24 JUNE 2016. DOI: 10.1136/NEURINTSURG-2016-012370.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235730 NAVIEN INTRACRANIAL CATHETER CATHETER, PERCUTANEOUS DQY COVIDIEN (IRVINE) RFXA058-125-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention