BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SMART COIL

    MDR report key: 21955615 · Received May 2, 2025

    Report

    Report Number
    3005168196-2025-00153
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K160832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, AN INVESTIGATION CANNOT BE PERFORMED. PENUMBRA WAS UNABLE TO OBTAIN ENOUGH DEVICE INFORMATION TO IDENTIFY THE CATALOG NUMBER. THE ONLY DEVICE IDENTIFIERS KNOWN ARE: D1(BRAND NAME), D2A (COMMON DEVICE NAME), AND D2B (PRODUCT CODE). WITHOUT THE CATALOG NUMBER FOR THIS DEVICE, UNIQUE DEVICE IDENTIFIER (UDI) CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 0

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 07-APR-2025, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "UNEXPECTED COIL MASS MIGRATION DURING TRANSVENOUS EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTULA RESOLVED WITH GUIDEWIRE-ASSISTED SNARING TECHNIQUE" (CHIHARA ET AL. 2025).THE EVENT DATE WAS NOT PROVIDED; HOWEVER, THE ARTICLE WAS PUBLISHED ON 15-APR-2024 AND DOCUMENTS A SINGLE CASE OF TRANSVERSE-SIGMOID SINUS DURAL ARTERIOVENOUS FISTULAS (TSDAVF) EMBOLIZATION USING A PENUMBRA SMART COIL (SMART COIL). WHILE PERFORMING THE TSDAVF EMBOLIZATION PROCEDURE, THE DECISION WAS MADE TO OCCLUDE BOTH THE TRANSVERSE AND SIGMOID SINUSES WHILE PRESERVING THE VEIN OF LABBE. IT WAS REPORTED THAT FIVE NON-PENUMBRA COILS WERE PLACED FOR FRAMING FOLLOWED BY ANOTHER NON-PENUMBRA COIL AND A PENUMBRA SMART COIL (SMART COIL). HOWEVER, DUE TO THE COIL PRESSURE AND BLOOD FLOW, THE COIL MASS HAD UNEXPECTEDLY MOVED TO THE VASCULAR CONFLUENCE. IT WAS REPORTED THAT LEAVING THE COIL MASS AT THE CONFLUENCE COULD HAVE IMPEDED NORMAL VENOUS CIRCULATION VIA THE SUPERIOR SINUS AND STRAIGHT SINUS. THUS, THE RETRIEVAL OF THE COIL MASS WAS DEEMED NECESSARY. THE PHYSICIAN THEN ADVANCED NON-PENUMBRA MICROCATHETERS THROUGH THE COIL MASS TO THE RIGHT TRANSVERSE SINUS AND A SNARE DEVICE WAS DEPLOYED IN THE TRANSVERSE SINUS. THE PHYSICIAN ADVANCED A GUIDEWIRE THROUGH THE COIL MASS TO THE RIGHT TRANSVERSE SINUS AND WAS PASSED THROUGH THE SNARE DEVICE. THE SNARE DEVICE WAS THEN USED TO CATCH THE GUIDEWIRE, AND A LOOP WAS CREATED USING THE MICROCATHETER, SNARE DEVICE, GUIDEWIRE AND MICROCATHETER. THE COIL MASS WAS RETRACTED PROXIMALLY TO THE VEIN OF LABBE USING THE GUIDEWIRE-ASSISTED SNARING TECHNIQUE TO ACHIEVE EMBOLIZATION. SUBSEQUENTLY, WHILE MAINTAINING THE LOCKING LOOP, ANOTHER NON-PENUMBRA MICROCATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN (FV) APPROACH AND WAS ADVANCED TO THE COIL MASS TO COMPLETE THE EMBOLIZATION. THE TSDAVF DISAPPEARED FOLLOWING THE SINUS EMBOLIZATION AND ALL DEVICES WERE RETRIEVED WITH HEMOSTASIS PERFORMED MANUALLY. IT WAS REPORTED THAT TSDAVF RESOLVED AFTER THE ENDOVASCULAR EMBOLIZATION WITH NO POSTOPERATIVE ISCHEMIC OR HEMORRHAGIC COMPLICATIONS. THE PATIENT'S COGNITIVE AND EXECUTIVE FUNCTIONS ALSO IMPROVED FROM MINI-MENTAL STATE EXAMINATION (MMSE) SCORE OF 16/30 AND FRONTAL ASSESSMENT BATTERY (FAB) SCORE OF 7/18 TO MMSE: 21/30 AND FAB: 12/18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423682 PENUMBRA SMART COIL HCG,KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male