BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 12783717 · Received November 9, 2021

    Report

    Report Number
    3013353964-2021-00003
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 5, 2021
    Manufacturer
    SHAPE MEMORY MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00810041650047
    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 IN THE EU TO TREAT A PAVM AND AFTER DEPLOYMENT IT MIGRATED FROM THE ITS TARGET SITE AND EMBOLIZED A VESSEL IN THE PATIENT'S HAND. BASED ON SHAPE MEMORY MEDICAL'S REVIEW OF THE CASE ANGIOGRAMS 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 COMBINATION OF IMPEDE AND IMPEDE-FX DEVICES WERE USED TO TREAT A PAVM. AFTER THE PHYSICIAN DELIVERED AN IMPEDE AND AN IMPEDE-FX DEVICE TO THE FIRST FEEDER VESSEL (5.7 MM DIAMETER), RESIDUAL SAC FLOW COMING FROM A SECOND FEEDER VESSEL WAS OBSERVED. THE PHYSICIAN THEN TRIED DEPLOYING AN IMP-FX-08 TO OCCLUDE THIS VESSEL, HOWEVER, POSSIBLY DUE TO HIGH FLOW IN THE VICINITY, THE DEVICE MIGRATED TO ANOTHER VESSEL. THEREAFTER, HAVING FOUND NO PLUG IN THE PATIENT'S CAROTID, THE CASE WAS COMPLETED USING ANOTHER IMPEDE DEVICE AND A CT SCAN PERFORMED AFTERWARDS LOCATED THE MISSING IMP-FX-08 DEVICE IN THE PATIENT'S HAND. AS OF (B)(6) 2021, ALTHOUGH THE PATIENT REPORTED NO COMPLAINTS, IT WAS DECIDED THAT THE PLUG WOULD BE REMOVED VIA PLASTIC SURGERY DUE TO THE APPEARANCE OF A RED SPOT ON THE SKIN OF THE PATIENT'S PALM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677242 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL INC. IMP-FX-08 00810041650047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown