BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 14156753 · Received April 20, 2022

    Report

    Report Number
    3005168196-2022-00183
    Event Type
    Death
    Date Received
    April 20, 2022
    Date of Event
    January 1, 2011
    Report Date
    April 20, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 PENUMBRA SYSTEM INSTRUCTIONS FOR USE (IFU) INCLUDE, BUT ARE NOT LIMITED TO, DISTAL EMBOLIZATION, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, VESSEL SPASM, THROMBOSIS, DISSECTION, ISCHEMIA, INCLUDING DEATH. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2022-00182.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 25-MAR-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "EMERGENT CAROTID ARTERY STENTING IN PATIENTS WITH ACUTE ISCHEMIC STROKE DUE TO CERVICAL INTERNAL CAROTID ARTERY STENO-OCCLUSIVE LESION: COMPARISON OF TANDEM INTRACRANIAL OCCLUSION AND ISOLATED CERVICAL INTERNAL CAROTID ARTERY OCCLUSION" (PARK ET AL. 2020). THIS ARTICLE RETROSPECTIVELY REVIEWED FORTY-SIX PATIENTS WHO UNDERWENT ENDOVASCULAR THROMBECTOMY PROCEDURES BETWEEN JANUARY 2011 AND NOVEMBER 2018 INVOLVING THE USE OF A PENUMBRA SYSTEM REPERFUSION CATHETER. IT WAS REPORTED THAT SEVEN PATIENTS EXPERIENCED A SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH) FOLLOWING ENDOVASCULAR TREATMENT. HOWEVER, THE RELATIONSHIP BETWEEN THE SICHS AND THE PENUMBRA SYSTEM REPERFUSION CATHETER WAS NOT SPECIFIED. IT WAS ALSO REPORTED THAT FIVE PATIENTS DIED FROM ACUTE CEREBRAL HEMORRHAGE EVEN AFTER DECOMPRESSIVE CRANIECTOMY. HOWEVER, THE RELATIONSHIP BETWEEN THE HEMORRHAGES AND THE PENUMBRA SYSTEM REPERFUSION CATHETER WAS NOT SPECIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, NOR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL MALFUNCTIONS AND/OR ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274119 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death