BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER

    MDR report key: 3885107 · Received June 19, 2014

    Report

    Report Number
    3005168196-2014-00410
    Event Type
    Death
    Date Received
    June 19, 2014
    Date of Event
    November 24, 2013
    Report Date
    May 23, 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 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 3005168196-2014-00411. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) CHOROID USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER AND 5MAX SEPARATOR. BEFORE THE PROCEDURE, INTRAVENOUS TISSUE PLASMINOGEN WAS NOT ADMINISTERED. DURING THE PROCEDURE, A 5MAX REPERFUSION CATHETER WAS ADVANCED TO THE C4 ALONG WITH ANOTHER MANUFACTURERS GUIDE WIRE AND BALLOON GUIDING CATHETER. ASPIRATION WAS COMPLETED WITH A 5MAX SEPARATOR AND 3,000 UNITS OF HEPARIN WERE INJECTED. SIX HOURS POST-PROCEDURE THE PATIENTS' CONSCIOUSNESS LEVEL DECREASED WITHOUT NOTICE AND DEVELOPED AN INTRACRANIAL HEMORRHAGE. THE PHYSICIAN MONITORED THE PATIENT'S CONDITION BUT WITHHELD ANY ADDITIONAL TREATMENT. SUBSEQUENTLY, THE PATIENT EXPIRED TWO DAYS LATER. AN AUTOPSY WAS NOT PERFORMED; HOWEVER, IT IS BELIEVED THAT THE CAUSE OF DEATH WAS CEREBRAL EDEMA. THE PATIENT HAD A HEMATOMA, WHICH COVERED MORE THAN 30 % OF THE INFARCT AREA. PHYSICIAN'S COMMENTS: THE PATIENT DEVELOPED HEMORRHAGIC INFARCT COMPLICATED WITH RECANALIZATION. I CANNOT DENY THAT THE EVENT WAS RELATED TO THE PENUMBRA SYSTEM AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361284 PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F35409

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death