BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 16454668 · Received February 28, 2023

    Report

    Report Number
    3013353964-2023-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 27, 2023
    Manufacturer
    SHAPE MEMORY MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00810041650054
    PMA / PMN Number
    K182390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TREATMENT OF PELVIC CONGESTION SYNDROME, OVARIAN VEIN WAS BEING EMBOLIZED. AFTER DEPLOYING A COMBINATION OF IMP-10 AND IMP-FX-12 PLUGS, SUBSEQUENT MIGRATION OF THE LAST IMP-FX-12 PLUG WAS NOTICED FROM OVARIAN VEIN TO RENAL VEIN. PHYSICIAN THEN DEPLOYED THE INFERIOR VENA CAVA FILTER AND THE MIGRATED PLUG WAS CAPTURED AND REMOVED WITH AN ENDOVASCULAR SNARE. EXPLANTED PLUG WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO MANUFACTURER FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, PROCEDURE WAS PERFORMED AS INTENDED, HOWEVER THE CAUSE OF MIGRATION OF THE LAST IMP-FX-12 PLUG IS UNKNOWN. IT WAS ALSO REPORTED THAT PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE EVENT TO PATIENT. A REVIEW OF THE LOT HISTORY RECORD AND ACCOMPANYING LOT RELEASE REPORT IDENTIFIED NO QUALITY ISSUES RELATED TO DEVICE PERFORMANCE. 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 NUMBER: 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 INDICATIONS FOR USE IN EU AND US, SMM IS CHOOSING TO REPORT THIS INCIDENT TO FDA BECAUSE OF THE GENERAL SIMILARITIES BETWEEN THE TWO REGIONS. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE RECEIVED FROM THE COMPLAINANT. SHAPE MEMORY MEDICAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH A PELVIC CONGESTION SYNDROME AND OVARIAN VEIN WAS BEING EMBOLIZED. AFTER DEPLOYING A COMBINATION OF IMP-10 AND IMP-FX-12 PLUG IN THE OVARIAN VEIN, SUBSEQUENT MIGRATION OF THE IMP-FX-12 PLUG WAS NOTICED FROM OVARIAN VEIN TO RENAL VEIN. THEREAFTER, INFERIOR VENA CAVA FILTER WAS DEPLOYED, AND THE MIGRATED PLUG WAS CAPTURED AND REMOVED WITH AN ENDOVASCULAR SNARE. EXPLANTED PLUG WAS DISCARDED BY THE HOSPITAL. BASED ON THE INFORMATION RECEIVED, NO SERIOUS ADVERSE EVENT TO PATIENT OCCURRED. IT WAS REPORTED THAT THE FINAL OUTCOME WAS SATISFACTORY, AND THE PATIENT HAD NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657481 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL INC. IMP-FX-12 F22082401U 00810041650054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention