BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 14149016 · Received April 19, 2022

    Report

    Report Number
    3005168196-2022-00179
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    January 1, 2015
    Report Date
    April 19, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE 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, ISCHEMIA, INCLUDING DEATH. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2022-00180.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON (B)(6) 2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "ANGIOGRAPHIC EARLY HYPEREMIA IN THE MIDDLE CEREBRAL ARTERY TERRITORY AFTER THROMBECTOMY IS ASSOCIATED WITH FAVORABLE CLINICAL OUTCOME IN ANTERIOR CIRCULATION STROKE" (LIN ET AL. 2021). THIS ARTICLE RETROSPECTIVELY REVIEWED ONE-HUNDRED AND FORTY-THREE PATIENTS WHO UNDERWENT ENDOVASCULAR THROMBECTOMY PROCEDURES BETWEEN JANUARY 2015 AND SEPTEMBER 2018 INVOLVING THE USE OF PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), AND PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC). IT WAS REPORTED THAT TWENTY-EIGHT PATIENTS WHO UNDERWENT THROMBECTOMY PROCEDURES IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER EXPERIENCED POSTPROCEDURAL INTRAPARENCHYMAL HEMORRHAGES (PH). IT WAS REPORTED THAT SEVENTEEN PATIENTS EXPERIENCED TYPE PH1, AND ELEVEN PATIENTS EXPERIENCED TYPE PH2. HOWEVER, THE RELATIONSHIP BETWEEN THE PHS AND THE PENUMBRA SYSTEM REPERFUSION CATHETER WAS NOT SPECIFIED. IT WAS ALSO REPORTED THAT TWELVE PATIENTS WHO UNDERWENT THROMBECTOMY PROCEDURES IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM REPERFUSION CATHETER EXPERIENCED POSTPROCEDURAL SYMPTOMATIC INTRACRANIAL HEMORRHAGE (SICH). HOWEVER, THE RELATIONSHIP BETWEEN THE SICHS 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
    1265787 PENUMBRA SYSTEM REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other