BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA COIL 400

    MDR report key: 14527153 · Received May 27, 2022

    Report

    Report Number
    3005168196-2022-00237
    Event Type
    Malfunction
    Date Received
    May 27, 2022
    Date of Event
    November 1, 2017
    Report Date
    May 27, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    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.

    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, "ENDOVASCULAR TREATMENT OF MEDIUM AND LARGE INTRACRANIAL ANEURYSMS WITH LARGE VOLUME COILS: A SINGLE CENTER EXPERIENCE" (SAAL-ZAPATA ET AL. 2022). IN THIS SINGLE CENTER RETROSPECTIVE REVIEW, THIRTY-THREE PATIENTS WITH RUPTURED AND UNRUPTURED INTRACRANIAL ANEURYSMS WERE TREATED BETWEEN NOVEMBER 2017 AND SEPTEMBER 2019 USING PENUMBRA COIL 400S (PC400S), A PENUMBRA COIL DETACHMENT HANDLE (HANDLE), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND A GUIDEWIRE (0.014¿). ONE PATIENT WHO UNDERWENT A STENT-ASSISTED COILING (SAC) PROCEDURE TO TREAT A RUPTURED PARACLINOID ANEURYSM USING PC400S EXPERIENCED INTRAPROCEDURAL COIL PROTRUSION INTO THE PARENT ARTERY. DESPITE STENTING, INTERNAL CAROTID ARTERY (ICA) THROMBOSIS OCCURRED WITHOUT CLINICAL CONSEQUENCES DUE TO A PATENT ANTERIOR COMMUNICATING ARTERY (ACA). IT WAS ALSO REPORTED THAT ONE PC400 MIGRATED WITHIN THE VESSEL, BUT WITHOUT CLINICAL CONSEQUENCES. 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
    2192847 PENUMBRA COIL 400 HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female