BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12483001 · Received September 16, 2021

    Report

    Report Number
    3005168196-2021-02064
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 1, 2015
    Report Date
    September 16, 2021
    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

    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, INTRACRANIAL HEMORRHAGE, EMBOLIC STROKE AND OTHER CEREBRAL ISCHEMIC EVENTS, ANEURYSM RUPTURE, ARTERIOVENOUS FISTULA, 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 (B)(6) 2021, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "EARLY EXPERIENCE WITH THE PENUMBRA SMART COIL IN THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ANEURYSMS: SAFETY AND EFFICACY" (STAPLETON ET AL. 2016). IN THIS SINGLE-CENTER RETROSPECTIVE REVIEW, SEVENTEEN PATIENTS WERE TREATED WITH PENUMBRA SMART COILS (SMART COILS) BETWEEN AUGUST 2015 AND JANUARY 2016. IT WAS REPORTED THAT ONE PATIENT WITH A HIGH-GRADE SUBARACHNOID HEMORRHAGE (SAH) SUFFERED A THROMBOEMBOLIC COMPLICATION OF UNCLEAR CLINICAL SIGNIFICANCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 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
    1377657 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other