BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 12844887 · Received November 19, 2021

    Report

    Report Number
    3013353964-2021-00004
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 18, 2021
    Manufacturer
    SHAPE MEMORY MEDICAL, INC.
    Product Code
    KRD
    UDI-DI
    00810041650030
    PMA / PMN Number
    K182390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPEDE-FX DEVICE WAS BEING USED TO TREAT A PAVM WHICH RECANALIZED AND AFTER DEPLOYMENT IT MIGRATED FROM THE ITS TARGET SITE (I.E., SUBSEGMENTAL BRANCH OF LATERAL MIDDLE LOBE) AND EMBOLIZED A SUB-SUBSEGMENTAL BRANCH. BASED ON SHAPE MEMORY MEDICAL'S (SMM) REVIEW OF THE DEVICE DEPLOYMENT VIDEOS PROVIDED, NO ROOT CAUSE CAN BE DEFINITELY ATTRIBUTED TO THE DEVICE MIGRATION. IT IS BELIEVED, BUT CANNOT BE CONFIRMED THAT THE DEVICE MIGRATED DUE TO HIGH FLOW IN THE VICINITY OF VESSEL IT WAS DEPLOYED TO. NOTE: THE IMPEDE-FX INDICATIONS FOR USE IN THE EU AND US ARE DIFFERENT. IN THE EU, THE IMPEDE-FX IS INDICATED TO OBSTRUCT OR REDUCE THE RATE OF BLOOD FLOW IN THE PERIPHERAL VASCULATURE. COMPARATIVELY, IN THE US, THE IMPEDE-FX IS INDICATED FOR USE WITH THE IMPEDE EMBOLIZATION PLUG TO OBSTRUCT OR REDUCE THE RATE OF BLOOD FLOW IN THE PERIPHERAL VASCULATURE; THIS MEANS IMPEDE-FX MUST BE USED WITH THE IMPEDE (510K #: K181051) TO MITIGATE MIGRATION RISKS. IN BOTH THE EU AND US, IMPEDE-FX IS USED FOR PERIPHERAL VESSEL EMBOLIZATION AND IS IDENTICAL WITH REGARDS TO FORM, FIT AND FUNCTION. THEREFORE, REGARDLESS OF THE DIFFERENCES IN THE EU AND US IMPEDE-FX INDICATIONS, SMM IS CHOOSING TO REPORT THIS INCIDENT TO THE FDA BECAUSE OF THE GENERAL SIMILARITIES BETWEEN THE TWO REGIONS. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE RECEIVED FROM THE COMPLAINANT.

    Description of Event or Problem · 0

    A PATIENT PRESENTED WITH A PAVM (2.6 MM IN DIAMETER) WHICH HAD RECANALIZED AFTER PREVIOUSLY BEING EMBOLIZED USING COILS (NOT MANUFACTURED BY SMM). AN IMP-FX-06 DEVICE WAS CHOSEN FOR DELIVERY TO A SITE PROXIMAL TO THE PREVIOUSLY IMPLANTED COILS WITH NO SIDE BRANCHES IN THE VICINITY. DURING 4F MP CATHETER WITHDRAWAL, THE IMP-FX PLUG MIGRATED FROM THE SUB-SEGMENTAL BRANCH WHERE IT WAS DEPLOYED TO ANOTHER SUB-SUBSEGMENTAL BRANCH. IT WAS REPORTED THE PATIENT HAD EXPERIENCED DYSPNEA ONCE A DAY OR TWO AFTER THE PROCEDURE, BUT NOW HAS A STABLE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744411 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL, INC. IMP-FX-06 F21022203 00810041650030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown