BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 5101180 · Received September 24, 2015

    Report

    Report Number
    3008853977-2015-00391
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    February 1, 2014
    Report Date
    September 10, 2015
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    MJN
    PMA / PMN Number
    K122576
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THROMBOEMBOLISM IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED FROM JANUARY 2013 TO FEBRUARY 2014. THE DEVICE WAS DISPOSED IN THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE THAT DURING THE TREATMENT OF AN INTRACRANIAL ANEURYSM USING REMODELING TECHNIQUE WITH THE SUBJECT OCCLUSION BALLOON CATHETER, THE PATIENT HAD PROCEDURAL THROMBOEMBOLIC EVENT (TE) RELATED TO THE REMODELING TECHNIQUE. TE RESULTED IN AN OCCLUSION OF THE INFERIOR ARTERY BRANCH DURING THE TREATMENT OF A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WHICH WAS PROMPTLY REOPENED WITH BALLOON ANGIOPLASTY WITHOUT DISTAL MIGRATION OF THE CLOT OR ISCHEMIC COMPLICATION. THE COMPLICATION WAS RESOLVED WITHOUT PERMANENT CLINICAL EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE THAT DURING THE TREATMENT OF AN INTRACRANIAL ANEURYSM USING REMODELING TECHNIQUE WITH THE SUBJECT OCCLUSION BALLOON CATHETER, THE PATIENT HAD PROCEDURAL THROMBOEMBOLIC EVENT (TE) RELATED TO THE REMODELING TECHNIQUE. TE RESULTED IN AN OCCLUSION OF THE INFERIOR ARTERY BRANCH DURING THE TREATMENT OF A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM, WHICH WAS PROMPTLY REOPENED WITH BALLOON ANGIOPLASTY WITHOUT DISTAL MIGRATION OF THE CLOT OR ISCHEMIC COMPLICATION. THE COMPLICATION WAS RESOLVED WITHOUT PERMANENT CLINICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630322 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN STRYKER NEUROVASCULAR CORK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention