BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 20791081 · Received November 27, 2024

    Report

    Report Number
    3013353964-2024-00011
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 7, 2024
    Report Date
    November 26, 2024
    Manufacturer
    SHAPE MEMORY MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00810041650054
    PMA / PMN Number
    K182390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE LOT HISTORY RECORD AND ACCOMPANYING LOT RELEASE REPORT IDENTIFIED NO QUALITY ISSUES RELATED TO DEVICE PERFORMANCE. A BENCHTOP INVESTIGATION COULD NOT OCCUR BECAUSE THE DEVICE REMAINS IMPLANTED IN THE PATIENT. BASED ON THE INFORMATION RECEIVED THUS FAR, NO ROOT CAUSE CAN DEFINITIVELY BE ATTRIBUTED TO THE DEVICE MIGRATION. ALTHOUGH, THE IMPEDE-FX US INSTRUCTIONS FOR USE STATE, "PHYSICIANS SHOULD EXERCISE CLINICAL JUDGEMENT WHEN USING THE IMPEDE-FX EMBOLIZATION PLUG IN ANATOMY THAT MAY LEAD TO UNINTENDED DEVICE PLACEMENT AND/OR MOVEMENT (I.E., HIGH FLOW VASCULATURE, LARGE LUMINAL VESSEL DIAMETER)." IT IS BELIEVED, BUT CANNOT BE CONFIRMED THAT THE DEVICE MAY HAVE MIGRATED DUE TO HIGH FLOW IN THE VICINITY OF THE VESSEL IT WAS DEPLOYED TO. NO ADVERSE EVENT TO THE PATIENT HAS BEEN REPORTED THUS FAR. HOWEVER, A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE RECEIVED FROM THE COMPLAINANT. NOTE: THE IMPEDE-FX US INDICATIONS FOR USE ALSO STATE THAT "THE IMPEDE-FX EMBOLIZATION PLUG IS INDICATED FOR USE WITH THE IMPEDE EMBOLIZATION PLUG TO OBSTRUCT OR REDUCE THE RATE OF BLOOD FLOW IN THE PERIPHERAL VASCULATURE;" THIS MEANS THE IMPEDE-FX DEVICE IS INDICATED TO BE USED WITH THE IMPEDE DEVICE (510K NUMBER: K181051) TO MITIGATE MIGRATION RISKS. THE PATIENT WAS IMPLANTED WITH 7 IMP-FX-12 DEVICES ONLY. SHAPE MEMORY MEDICAL INC. COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2024, DR (B)(6) AT (B)(6) PERFORMED AN EMBOLIZATION OF AN OVARIAN VEIN WHERE 6 OF 7 IMP-FX-12 PLUGS WERE DELIVERED AT THE TARGET SITE USING A 6F CORDIS CATHETER. 1 IMP-FX-12 PLUG HAD MIGRATED AND LANDED IN A SUB-SEGMENTAL PULMONARY ARTERY THAT WAS PERFUSING A SMALL PART OF THE LUNG. DR (B)(6) OPTED NOT TO ATTEMPT TO RETRIEVE THE MIGRATED PLUG AS THERE WAS NO PATIENT SEQUELAE. THE PROCEDURE WAS COMPLETED AND PATIENT IS IN STABLE CONDITION. NO ADVERSE EVENT HAS BEEN REPORTED THUS FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850370 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL INC. IMP-FX-12 F23013101U 00810041650054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown