BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 054

    MDR report key: 3675821 · Received March 12, 2014

    Report

    Report Number
    3005168196-2014-00170
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    July 26, 2012
    Report Date
    February 13, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00158, 00166, 00167, 00168 AND 00169. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT C4 USING THE PENUMBRA SYSTEM REPERFUSION CATHETER 032/054 AND THE PENUMBRA SYSTEM SEPARATOR 032/054. BEFORE THE PROCEDURE, 21,240,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV T-PA) WERE ADMINISTERED. DURING THE PROCEDURE, A REPERFUSION CATHETER 054 AND 032 WERE ADVANCED TO THE TARGET VESSEL ALONG A RADIFOCUS GUIDE WIRE GT 0.016 INCH THROUGH AN OPTIMO GUIDE CATHETER 9FR. DURING THIS PROCEDURE, EXTRAVASATION OCCURRED IN THE INTERNAL CAROTID ARTERY (ICA). THE PATIENT WAS THEN GIVEN 3,000 UNITS OF HEPARIN. POSTOPERATIVELY BARBITURATE NARCOSIS THERAPY WAS GIVEN TO THE PATIENT FOR CEREBROPROTECTION AND APPEASE. JUST AFTER THE OPERATION, A COMPUTED TOMOGRAPHY (CT) REVEALED THAT THE PATIENT DEVELOPED EXTENSIVE INFARCT IN THE LEFT HEMISPHERE. THE FOLLOWING CT SHOWED THAT THE PATIENT SUFFERED EXTENSIVE INFARCT IN THE RIGHT CEREBRUM. COIL EMBOLIZATION WAS CONDUCTED IN THE PERFORATED ICA. THE PHYSICIAN COULD STOP HEMORRHAGE BUT ABANDONED REVASCULARIZATION. MANNITOL AND EDARAVONE WERE INJECTED. THE FOLLOWING DAY, EXTERNAL DECOMPRESSION WAS DONE. THE PATIENT LOST PUPILLARY LIGHT REFLEX AND BECAME BRAIN DEAD. THE PATIENT WAS MONITORED UNDER ANESTHESIA APPROXIMATELY ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT EXPIRED. PHYSICIAN'S COMMENT: THIS EXTRAVASATION WAS A SERIOUS ADVERSE EVENT RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE. THE PATIENT SUFFERED CARDIOGENIC OCCLUSION IN THE RIGHT ICA, WHERE NO OPERATION WAS PERFORMED. SO THIS EVENT WAS NOT RELATED TO THE PENUMBRA SYSTEM OR THE PROCEDURE. I CONSIDERED THIS EVENT AS A SERIOUS ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146972 PENUMBRA SYSTEM SEPARATOR 054 NRY NRY PENUMBRA, INC. F23370

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other