BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12543877 · Received September 28, 2021

    Report

    Report Number
    3005168196-2021-02138
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    April 12, 2021
    Report Date
    December 31, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2021-02138. 1. SECTION H. BOX 6. PATIENT CODE 1. SECTION H. BOX 6. PATIENT CODE 1: 4581 - APPROPRIATE CODE NOT AVAILABLE TO DESCRIBE "SILENT CEREBRAL INFARCTION".

    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, ANEURYSM RUPTURE, EMBOLI, EMBOLIC STROKE AND OTHER CEREBRAL ISCHEMIC EVENTS, NEUROLOGICAL DEFICITS INCLUDING STROKE, ISCHEMIA, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT WAS AN ANTICIPATED COMPLICATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR BIFURCATION ANEURYSM USING A PENUMBRA SMART COIL (SMART COIL) WITHOUT ANY PROCEDURAL COMPLICATIONS. ON (B)(6) 2021, A CONTROL SCAN WAS TAKEN AND MULTIPLE SUBACUTE DIFFUSION-WEIGHTED IMAGING (DWI) LESIONS WITHOUT CLINICAL SEQUEL WERE NOTED. THERE WAS NO CLINICAL CORRELATION AND THE PATIENT DID NOT REQUIRE ANY TREATMENT. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED HOME WITH NO SYMPTOMS. THE SILENT CEREBRAL INFARCTION WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE SMART COIL AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438902 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other