BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 17592178 · Received August 21, 2023

    Report

    Report Number
    3013353964-2023-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 11, 2023
    Report Date
    August 16, 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
    AU
    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 DID NOT OCCUR BECAUSE THE DEVICE WAS DISCARDED AND COULD NOT BE RETURNED TO SHAPE MEMORY MEDICAL. BASED ON THE INFORMATION RECEIVED, THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT IS THE PHYSICIAN DID NOT WAIT LONG ENOUGH FOR THE SECOND IMP-FX-12 DEVICE TO EXPAND PRIOR TO DELIVERING THE THIRD IMP-FX-12 DEVICE. ONLY TWO MINUTES HAD ELAPSED AFTER THE SECOND IMP-FX-12 DEVICE WAS DEPLOYED. THEREFORE, WHEN THE GUIDEWIRE WAS MANIPULATED THIS CAUSED THE SECOND IMP-FX-12 DEVICE TO MIGRATE OUTSIDE THE DELIVERY SITE. THE IMPEDE-FX EU INSTRUCTIONS FOR USE STATE THAT THE USER SHOULD "WAIT A MINIMUM OF FIVE MINUTES AFTER DEVICE DEPLOYMENT TO VERIFY EMBOLIZATION AND DEVICE EXPANSION HAS OCCURRED VIA ANGIOGRAPHY." 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 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 CHOSING 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

    A DISTAL LEFT OVARIAN VEIN WAS BEING TREATED. AFTER DELIVERING SIX PENUMBRA RUBY COILS AROUND THE VESSEL BIFURCATION, TWO IMP-FX-12 DEVICES WERE DEPLOYED PROXIMAL TO THE RUBY COIL. TWO MINUTES AFTER DEPLOYMENT, THE PHYSICIAN MANIPULATED THE GUIDEWIRE IN PREPARATION FOR DELIVERY OF A THIRD IMP-FX-12 DEVICE. THE GUIDEWIRE MOVEMENT CAUSED THE SECOND IMP-FX-12 PLUG TO MIGRATE TO THE PATIENT'S LUNG. TWO HOURS LATER THE DEVICE WAS SNARED AND EXPLANTED USING AN 8F GUIDING SHEATH. THE PHYSICIAN STATED THAT THE INCIDENT WAS NOT DEVICE-RELATED AND ACKNOWLEDGED THAT THEY "SHOULD HAVE BEEN MORE PATIENT TO ALLOW THE PLUGS TO EXPAND TO AVOID MIGRATION." NO ADVERSE EVENT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496295 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL INC. IMP-FX-12 F21060101 00810041650054

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Unknown Required Intervention| R