BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER

    MDR report key: 15403767 · Received September 12, 2022

    Report

    Report Number
    3005168196-2022-00421
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    December 1, 2012
    Report Date
    September 12, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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. INTRACRANIAL HEMORRHAGE IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE PENUMBRA SYSTEM. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2022-00420, 3005168196-2022-00422.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 16-AUG-2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "EXPERIENCE WITH A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT) FOR THROMBECTOMY IN DISTAL CEREBRAL ARTERY OCCLUSIONS CAUSING ACUTE ISCHEMIC STROKE" (VARGAS ET AL. 2017). IN THIS SINGLE CENTER RETROSPECTIVE REVIEW, THIRTY-FIVE CONSECUTIVE PATIENTS UNDERWENT MECHANICAL THROMBECTOMY PROCEDURES TO TREAT DISTAL CEREBRAL ARTERY OCCLUSIONS CAUSING ACUTE ISCHEMIC STROKE (AIS) USING A PENUMBRA SYSTEM 5MAX REPERFUSION CATHETER (5MAXC) IN FIVE PATIENTS, A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60) IN SEVEN PATIENTS, A PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER (4MAXC) IN SEVEN PATIENTS, AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) IN SIXTEEN PATIENTS BETWEEN DECEMBER 2012 AND APRIL 2015. IN ONE PATIENT WITH A LEFT INTERNAL CAROTID ARTERY (ICA) OCCLUSION WITH TANDEM OCCLUSIONS IN THE IPSILATERAL M2 AND A2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA), THROMBECTOMY WAS PERFORMED USING A PENUMBRA SYSTEM REPERFUSION CATHETER AND WAS COMPLICATED BY A NON-FLOW-LIMITING DISSECTION OF THE ICA. SUBSEQUENTLY, STENT PLACEMENT WAS PERFORMED. THE PATIENT DID NOT HAVE ANY NEUROLOGIC SYMPTOMS FROM ICA DISSECTION AND RETURNED WITH A NINETY-DAY MODIFIED RANKIN SCALE (MRS) SCORE OF ZERO. ONE PATIENT RECEIVED INTRAVENOUS TISSUE-TYPE PLASMINOGEN ACTIVATOR (IV TPA) BEFORE TRANSFER TO OUR INSTITUTION AND UNDERWENT A SUCCESSFUL MECHANICAL THROMBECTOMY PROCEDURE WITHOUT INCIDENT USING A PENUMBRA SYSTEM REPERFUSION CATHETER. SUBSEQUENTLY, THE PATIENT DEVELOPED A CLINICALLY SIGNIFICANT TYPE TWO PARENCHYMAL HEMORRHAGE. THE PATIENT HAD A SIGNIFICANT DECLINE IN THE NEUROLOGIC EXAMINATION POST-PROCEDURE, BECAME OBTUNDED, AND PROGRESSED TO COMPLETE HEMIPLEGIA. A HEAD COMPUTED TOMOGRAPHY SCAN (CT) DEMONSTRATED A 7.4 X 4.3 CENTIMETER RIGHT INTRACRANIAL HEMORRHAGE (ICH) WITH SIGNIFICANT MASS EFFECT. AFTER DISCUSSION WITH THE FAMILY, PALLIATIVE MEASURES WERE UNDERTAKEN, AND THE PATIENT WAS ULTIMATELY DISCHARGED TO HOSPICE. ANOTHER PATIENT PRESENTED WITH AN INITIAL THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF ZERO AND RECEIVED IV TPA BEFORE UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM REPERFUSION CATHETER SIX HOURS AFTER SYMPTOM ONSET. THE RECANALIZATION TIME IN THIS PATIENT WAS TWENTY MINUTES, AND THE PROCEDURE WAS UNCOMPLICATED. AFTER THROMBECTOMY, A SCORE OF TICI 2C WAS ACHIEVED. HOWEVER, THE PATIENT DEVELOPED A LARGE RIGHT-SIDED INTRAPARENCHYMAL HEMATOMA POST-THROMBECTOMY AND WAS SUBSEQUENTLY DISCHARGED TO HOSPICE. 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
    2215312 PENUMBRA SYSTEM REPERFUSION CATHETER QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization