BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 12651567 · Received October 18, 2021

    Report

    Report Number
    3005168196-2021-02314
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    February 14, 2021
    Report Date
    November 23, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548015972
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY THE CLINICAL INVESTIGATOR ON 03-NOV-2021: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2021-02309, 2. 3005168196-2021-02310, 3. 3005168196-2021-02311, 4. 3005168196-2021-02312, 5. 3005168196-2021-02313, 6. 3005168196-2021-02315, 7. 3005168196-2021-02316. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 03-NOV-2021 INDICATED THAT THE ISCHEMIC STROKE WAS ADJUDICATED BY THE CLINICAL INVESTIGATOR TO BE UNRELATED TO THE SMART COILS AND RELATED TO THE INDEX PROCEDURE.

    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 MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2021-02309, 3005168196-2021-02310, 3005168196-2021-02311, 3005168196-2021-02312, 3005168196-2021-02313, 3005168196-2021-02315, 3005168196-2021-02316.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) AND POSTERIOR COMMUNICATING ARTERY (PCOM) USING PENUMBRA SMART COILS (SMART COILS) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) WITHOUT ANY PROCEDURAL COMPLICATIONS OR DEVICE MALFUNCTIONS. ON (B)(6) 2021, A COMPUTED TOMOGRAPHY (CT) SCAN WAS TAKEN AND AN ISCHEMIC STROKE IN THE IPSILATERAL M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) WAS NOTED. SUBSEQUENTLY, THE PATIENT¿S BLOOD PRESSURE WAS MONITORED. THE PATIENT WAS ALSO ADMINISTERED MILD HEPARIN AND NO PROGRESSION OF THE STROKE WAS OBSERVED. THE PATIENT WAS IN STABLE CONDITION, INTUBATED AND ON ANALGESICS. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY WITH CLINICAL SEQUELAE. ON (B)(6) 2021, INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS UNRELATED TO THE SMART COILS AND PROBABLY RELATED TO THE INDEX PROCEDURE. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE ISCHEMIC STROKE WAS POSSIBLY RELATED TO THE SMART COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550016 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. 400SMTHXSFT0206 F82737 00814548015972

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention