BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 3813011 · Received May 15, 2014

    Report

    Report Number
    3005168196-2014-00309
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 10, 2013
    Report Date
    April 16, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    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 IS 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 3005168196-2014-00310. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT MIDDLE CEREBRAL ARTERY (MCA M1) USING A PENUMBRA SYSTEM REPERFUSION CATHETER 032 AND SEPARATOR 032. BEFORE THE PROCEDURE, THE PATIENT WAS GIVEN 20,880,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) AND UK WAS INJECTED. DURING THE PROCEDURE, THE REPERFUSION CATHETER 032 WAS ADVANCED TO THE M1 ALONG WITH A SYNCHRO 2 0.014 INCH THROUGH AN OPTIMO GUIDE CATHETER 9FR. ASPIRATION WAS CONDUCTED WITH THE SEPARATOR 032. THE PATIENT WAS THEN GIVEN 7,000 UNITS OF HEPARIN BY INJECTED. AN OPERATION WITH A MERCI RETRIEVER WAS ALSO COMPLETED. A POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SHOWED INTRACRANIAL HEMORRHAGE COMPLICATED WITH RECANALIZATION. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION BUT WITHHELD ANY ADDITIONAL TREATMENT. APPROXIMATELY, FOUR DAYS LATER, THE PATIENT EXPIRED DUE TO DETERIORATED INTRACRANIAL HEMORRHAGE. PHYSICIAN'S COMMENT: BASED ON THE OBSERVATION DURING OPERATION, POSTOPERATIVE ANGIOGRAPHY AND CT, THE EVENT WAS INTRACRANIAL HEMORRHAGE COMPLICATED WITH RECANALIZATION. I AM NOT SURE THAT THE EVENT WAS NOT RELATED TO THE PENUMBRA SYSTEM. THE EVENT WAS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290845 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F26253

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death