BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 20346964 · Received October 1, 2024

    Report

    Report Number
    3013353964-2024-00008
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 13, 2024
    Report Date
    October 1, 2024
    Manufacturer
    SHAPE MEMORY MEDICAL
    Product Code
    KRD
    UDI-DI
    10810041650051
    PMA / PMN Number
    K182390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT HISTORY RECORD FOR (B)(6) WAS REVIEWED AND IDENTIFIED NO QUALITY ISSUES RELATED TO DEVICE PERFORMANCE. A BENCHTOP INVESTIGATION WAS UNABLE TO OCCUR BECAUSE THE IMP-FX-12 DEVICES REMAINED IMPLANTED IN THE PATIENT. BASED ON THE INFORMATION RECEIVED THUS FAR, NO ROOT CAUSE CAN DEFINITIVELY BE ATTRIBUTED TO THE DEVICE MIGRATION. THE IMPEDE-FX US INSTRUCTIONS FOR USE ALSO 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 POSSIBLE, BUT CANNOT BE CONFIRMED, THAT THE DEVICES MIGRATED OUTSIDE OF THE AORTA DUE TO HIGH FLOW IN THE VICINITY OF THE VESSEL IT WAS DEPLOYED TO. FLOW WAS RESTORED TO THE PATIENT, NO OTHER ISSUES WERE NOTED DURING THE CASE, AND NO CLINICAL SEQUELAE HAS BEEN REPORTED SINCE. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE RECEIVED FROM THE COMPLAINANT. NOTE: 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. IT WAS NOT COMMUNICATED THAT AN IMPEDE EMBOLIZATION PLUG WAS USED IN THIS CASE. SHAPE MEMORY MEDICAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS WAS A FOLLOW UP CASE/RE-TREATMENT, PERFORMED ON (B)(6) 2024, TO TREAT A CHRONIC ENDOLEAK. THE ORIGINAL CASE TOOK PLACE ON (B)(6) 2024. DURING THE ORIGINAL CASE, 30 IMP-FX-12 PLUGS WERE USED TO TREAT THE ENDOLEAK. DURING FOLLOW UP/RE-TREATMENT ON (B)(6) 2024, IT WAS DISCOVERED THAT TWO IMP-FX-12 PLUGS FROM THE ORIGINAL CASE HAD MIGRATED FROM THE AORTA TO THE INTERNAL ILIAC AND RENAL ARTERIES. FLOW WAS RESTORED TO THE INTERNAL ILIAC WITH A STENT. FLOW WAS AVAILABLE TO THE KIDNEY VIA SIDE BRANCHES, SO NO ADDITIONAL MEASURES WERE TAKEN REGARDING THE IMPLANT IN THE RENAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46104 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL 10810041650051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention NESTER COILS, MWCE-35-20-16 (QTY: 2)| STENT GRAFT. MFG/MODEL UNKNOWN.