BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.5 FIRM EXT

    MDR report key: 3261231 · Received August 2, 2013

    Report

    Report Number
    0002954917-2013-00105
    Event Type
    Death
    Date Received
    August 2, 2013
    Date of Event
    April 12, 2013
    Report Date
    July 17, 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

    SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, HEMORRHAGE AND PATIENT OUTCOME OF DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE RETRIEVER WAS BEING USED IN THE OCCLUDED BASILAR ARTERY, AN EXTRAVASATION THAT RESULTED IN A SUBARACHNOID HEMORRHAGE (SAH) WAS OBSERVED. THE PHYSICIAN PERFORMED EXTERNAL VENTRICULAR DRAINAGE IN RESPONSE TO THE SAH. THE PATIENT DIED TWO DAYS POST PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT¿S CAUSE OF DEATH WAS DUE TO THE SAH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE RETRIEVER WAS BEING USED IN THE OCCLUDED BASILAR ARTERY, AN EXTRAVASATION THAT RESULTED IN A SUBARACHNOID HEMORRHAGE (SAH) WAS OBSERVED. THE PHYSICIAN PERFORMED EXTERNAL VENTRICULAR DRAINAGE IN RESPONSE TO THE SAH. THE PATIENT DIED TWO DAYS POST PROCEDURE. THE PHYSICIAN STATED THAT THE PATIENT¿S CAUSE OF DEATH WAS DUE TO THE SAH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362921 V 2.5 FIRM EXT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| R