BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 6301848 · Received February 3, 2017

    Report

    Report Number
    3005168196-2017-00134
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    October 13, 2016
    Report Date
    January 6, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT. 1. SECTION B. BOX 2. OUTCOMES ATTRIBUTED TO ADVERSE EVENT. 2. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND ARE BEING INCLUDED ON THIS FOLLOW-UP #02 MFR REPORT. 1. SECTION D. BOX 4. LOT NUMBER/CATALOG NUMBER/EXPIRATION DATE/UNIQUE IDENTIFIER. 2. SECTION H. BOX 4. DEVICE MANUFACTURE DATE. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2017-00330 2. 3005168196-2017-00331 3. 3005168196-2017-00332 H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT HAD UNDERGONE A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). HOWEVER, TWO HOURS POST-PROCEDURE, IT WAS CONFIRMED THAT THE PATIENT HAD BILATERAL ACUTE ACA INFARCTS, AND IT IS UNCERTAIN IF THIS CONDITION WAS RELATED TO THE SMART COIL SYSTEM. THE PATIENT DID NOT UNDERGO ANY ADDITIONAL TREATMENT TO TREAT THE INFARCTS. AS OF 9-FEB-2017, THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DEVICE IS NOT AVAILABLE FOR RETURN AS MENTIONED IN THE INITIAL MDR; THEREFORE, THE MDR WAS UPDATED ACCORDINGLY. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. 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: 3005168196-2017-00330, 3005168196-2017-00331, 3005168196-2017-00332 . THE DEVICE WAS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SUBMITTED UPON RECEIVING ADDITIONAL INFORMATION FROM THE HOSPITAL. THE HOSPITAL WILL PROVIDE A REASON WHY THE DEVICE IS NOT RETURNING LATER.

    Description of Event or Problem · 1

    THE PATIENT HAD BILATERAL ACUTE ANTERIOR CEREBRAL ARTERY (ACA) INFARCTS. AS OF (B)(6) 2017, THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82988 PENUMBRA SMART COIL HCG, KRD HCG PENUMBRA, INC. F67194

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening