BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER

    MDR report key: 11704563 · Received April 21, 2021

    Report

    Report Number
    3005168196-2021-00817
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    January 24, 2021
    Report Date
    March 24, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548016603
    PMA / PMN Number
    K161640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, DISSECTION, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, VESSEL SPASM, THROMBOSIS, ISCHEMIA, INCLUDING DEATH. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), A NON-PENUMBRA MICROCATHETER, AND A STENT RETRIEVER. AFTER ONE PASS USING THE ACE68 AND STENT RETRIEVER, RECANALIZATION WAS SUCCESSFULLY ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE OF 2B. NO PROCEDURAL COMPLICATIONS WERE REPORTED. ON (B)(6) 2021, THE PATIENT DEVELOPED SUBARACHNOID HEMORRHAGE (SAH) CAUSED BY DISSECTION OF THE LEFT INTERNAL CAROTID ARTERY (ICA). NO FURTHER TREATMENT WAS CONDUCTED PER WISHES OF THE PATIENT'S FAMILY AND THE PATIENT LATER EXPIRED. IT WAS REPORTED THAT THE ACE68 AND STENT RETRIEVER WERE RELATED TO THE VESSEL DISSECTION. THE CAUSE OF THE DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596085 PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. 5MAXACE068KIT F90942 00814548016603

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other