BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 11178094 · Received January 15, 2021

    Report

    Report Number
    3005168196-2021-00096
    Event Type
    Death
    Date Received
    January 15, 2021
    Date of Event
    August 1, 2015
    Report Date
    December 17, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SMART COIL SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, THROMBOEMBOLIC EPISODES, NEUROLOGICAL DEFICITS INCLUDING STROKE, PERIPHERAL THROMBOEMBOLIC EVENTS, INCLUDING DEATH. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 17-DEC-2020, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "LONG-TERM FOLLOW-UP RESULTS OF THE SMART COIL IN THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS." (MCAVOY ET AL. 2020). THIS ARTICLE REPORTS A SINGLE CENTER PROSPECTIVE ANALYSIS OF ONE HUNDRED AND FIVE PATIENTS UNDERGOING A TOTAL OF ONE HUNDRED AND SIX PROCEDURES UTILIZING AT LEAST ONE PENUMBRA SMART COIL (SMART COIL) BETWEEN AUGUST 2015 AND JULY 2018. DURING ONE PROCEDURE, AN INTRAOPERATIVE THROMBOEMBOLIC COMPLICATION OCCURRED IN WHICH AN OCCLUSION OF THE M2 AND M3 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) CAUSED A PARENCHYMAL DEFECT. FOLLOWING THE ADMINISTRATION OF 4000 UNITS OF INTRAVENOUS HEPARIN, THE DEGREE OF OCCLUSION IMPROVED. HOWEVER, ANOTHER PARENCHYMAL DEFECT CAUSED BY AN OCCLUSION IN THE RIGHT A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA) WAS DISCOVERED IN THE POST-OPERATIVE SETTING. POST-PROCEDURE, THE PATIENT BEGAN TO DECLINE NEUROLOGICALLY AND EXPIRED TWO DAYS POST-PROCEDURE. THERE WAS NO REPORTED PROCEDURAL COMPLICATION WITH A SMART COIL. IT SHOULD BE NOTED THAT IT IS UNCLEAR IF A SMART COIL WAS BEING USED WHEN THE THROMBOEMBOLIC COMPLICATION OCCURRED AND THE CAUSE OF DEATH WAS NOT SPECIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77836 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1