BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 9862831 · Received March 20, 2020

    Report

    Report Number
    3005168196-2020-00422
    Event Type
    Death
    Date Received
    March 20, 2020
    Date of Event
    April 11, 2019
    Report Date
    February 24, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, DISTAL EMBOLIZATION, NEUROLOGICAL DEFICITS INCLUDING STROKE, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENTS WERE ANTICIPATED COMPLICATIONS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K133317.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD). IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR NEW ONSET OF ATRIAL FIBRILLATION (AFIB) WITH RAPID VENTRICULAR RATE (RVR), DEVELOPED RIGHT FACIAL DROOP, AND RIGHT HEMIPARESIS. DURING THE PROCEDURE, THERE WERE NO REPORTED COMPLICATIONS, AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS ACHIEVED. PRE-PROCEDURE, THE PATIENT HAD A NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) OF SEVEN. TWENTY-FOUR HOURS POST-PROCEDURE ON (B)(6) 2019, THE PATIENT HAD A NIHSS OF THIRTEEN. ON (B)(6) 2019, A REPEAT COMPUTED TOMOGRAPHY (CT) SCAN SHOWED NEW SMALL RIGHT CORONA RADIATA HEMORRHAGE. ON (B)(6) 2019, THE PATIENT EXPIRED. THE PATIENT'S DEATH WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT RELATED TO THE JETD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325162 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death