BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 11169795 · Received January 14, 2021

    Report

    Report Number
    3005168196-2021-00090
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    July 1, 2016
    Report Date
    December 17, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, VESSEL SPASM, THROMBOSIS, DISSECTION, OR PERFORATION, 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, "SMART COILS FOR INTRACRANIAL ANEURYSM REPAIR ¿ A SINGLE CENTER EXPERIENCE." (DANIEL ET AL. 2020). THIS ARTICLE REPORTS A SINGLE-CENTER RETROSPECTIVE ANALYSIS OF FORTY-NINE PATIENTS WHO UNDERWENT PROCEDURES USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETERS BETWEEN JULY 2016 AND AUGUST 2018. THERE WAS NO REPORTED MALFUNCTION OR DEVICE-SPECIFIC COMPLICATION WITH ANY SMART COIL. HOWEVER, IT WAS REPORTED THAT ONE MICROCATHETER PROLAPSE AND FOUR THROMBOEMBOLIC COMPLICATIONS OCCURRED OF WHICH NONE HAD A CLINICAL SEQUELAE. IT SHOULD BE NOTED THAT THE MICROCATHETER PROLAPSE WAS NOT RELATED TO ANY PENUMBRA PRODUCT. IT WAS ALSO REPORTED THAT THERE WERE TOO MANY CONFOUNDING FACTORS TO CORRELATE THE FOUR THROMBOEMBOLIC COMPLICATIONS TO ANY SPECIFIC COIL. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69831 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other