BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM 5MAX REPEFUSION CATHETER

    MDR report key: 3825320 · Received May 21, 2014

    Report

    Report Number
    3005168196-2014-00323
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    October 30, 2013
    Report Date
    April 24, 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 3005168196-2014-00324. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BASILAR ARTERY (BA) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER AND SEPARATOR. BEFORE THE PROCEDURE, INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA) WAS NOT ADMINISTERED. DURING THE PROCEDURE, A 5MAX REPERFUSION CATHETER WAS ADVANCED TO THE BA ALONG WITH A TRANSCEND EX SOFT TIP 0.014 INCH THROUGH A ROADMASTER GUIDING CATHETER 8FR. ASPIRATION WAS CONDUCTED WITH A 5MAX SEPARATOR. THE PATIENT WAS GIVEN 4000 UNITS OF HEPARIN BY INJECTION. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND AN ADDITIONAL OPERATION WITH A MERCI RETRIEVER WERE DONE. AFTER THE OPERATION THE PATIENT DEVELOPED A CEREBRAL HEMORRHAGE IN THE THIRD AND THE FOURTH VENTRICLE, SUBARACHNOID HEMORRHAGE (SAH) IN THE BASAL CISTERN, AND INTRACRANIAL HEMORRHAGE BETWEEN THE MIDBRAIN AND THE PONS. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION BUT WITHHELD TREATMENT. UNFORTUNATELY, THE PATIENT EXPIRED APPROXIMATELY FIVE DAYS LATER. PHYSICIAN'S COMMENT: PERFORATION OF BA CAUSED HEMORRHAGE. THE PATIENT ALREADY DEVELOPED THE LETHAL PRIMARY DISEASE (BA OCCLUSION). I CANNOT DETERMINE HOW MUCH EFFECT THIS HEMORRHAGE HAD ON HER DEATH. I OFFERED PTA AND MERCI RETRIEVER AS ADDITIONAL TREATMENTS. THE RELATIONS BETWEEN THE EVENT AND THE PENUMBRA SYSTEM, AND THE EVENT AND THE PROCEDURE WERE POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302307 PENUMBRA SYSTEM 5MAX REPEFUSION CATHETER NRY NRY PENUMBRA, INC. F34680

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death