BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL

    MDR report key: 13553002 · Received February 17, 2022

    Report

    Report Number
    3005168196-2022-00065
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    April 1, 2019
    Report Date
    February 17, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2022-00063, 3005168196-2022-00064.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON (B)(6) 2022, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "MIGRATION OF NONFIBERED PACKING COILS USED TO TREAT PERIPHERAL PSEUDOANEURYSMS: REPORT OF 3 CASES" (GONZALEZ-ARAIZA ET AL. 2019). THIS ARTICLE REPORTS THREE CASES OF PENUMBRA COIL MIGRATION INTO THE LUMENS OF ADJACENT VISCERA: TWO INTO THE DUODENUM AND ONE INTO THE VAGINA. IN THE FIRST CASE STUDY, THE PHYSICIAN USED RUBY COILS AND POD PACKING COILS (POD PCS) TO EMBOLIZE THE GASTRODUODENAL ARTERY (GDA). DURING THE PROCEDURE, LOOPS OF THE FIRST POD PC (15MM) HERNIATED INTO THE PSEUDOANEURYSM; HOWEVER, THE GDA WAS SUCCESSFULLY EMBOLIZED. A COMPUTED TOMOGRAPHY SCAN (CT) PERFORMED FOUR DAYS POST-PROCEDURE SHOWED MIGRATION AND UNCOILING OF THE SECOND POD PC (15MM). ABDOMINAL RADIOGRAPH TAKEN ONE-MONTH POST-PROCEDURE REVEALED THAT THE POD PC HAD SPONTANEOUSLY PASSED. WHILE PERFORMING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN NOTICED A TWO-CENTIMETER PENUMBRA COIL (UNKNOWN) FRAGMENT PROTRUDING FROM THE DUODENAL LUMEN. SUBSEQUENTLY, ENDOSCOPIC GRASPERS WERE USED TO REMOVE THE PENUMBRA COIL FRAGMENT FROM THE PATIENT. THE PATIENT HAS BEEN ASYMPTOMATIC FOR MORE THAN ONE YEAR. 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
    28311 PENUMBRA COIL HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female