BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.0 SOFT EXT PTFE

    MDR report key: 3422783 · Received October 22, 2013

    Report

    Report Number
    0002954917-2013-00134
    Event Type
    Death
    Date Received
    October 22, 2013
    Date of Event
    March 20, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    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. HEMORRHAGE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED TWO PASSES WITH RETRIEVAL DEVICE TO TREAT A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) AFTER THE PROCEDURE. A VENTRICULAR DRAINAGE WAS PLACED TO TREAT THE SAH. THE PHYSICIAN STATED THAT THE SAH WAS CAUSED BY USING THE SUBJECT RETRIEVER AND THE CAUSE OF THE PATIENT DEATH WAS ¿THE INCREASE OF THE SUBARACHNOID HEMORRHAGE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED TWO PASSES WITH RETRIEVAL DEVICE TO TREAT A LEFT MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA SCORE OF 2B AFTER TREATMENT. THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) AFTER THE PROCEDURE. A VENTRICULAR DRAINAGE WAS PLACED TO TREAT THE SAH. THE PHYSICIAN STATED THAT THE SAH WAS CAUSED BY USING THE SUBJECT RETRIEVER AND THE CAUSE OF THE PATIENT DEATH WAS ¿THE INCREASE OF THE SUBARACHNOID HEMORRHAGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540285 V 2.0 SOFT EXT PTFE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death