BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 19262166 · Received May 7, 2024

    Report

    Report Number
    3013353964-2024-00005
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 8, 2024
    Report Date
    May 7, 2024
    Manufacturer
    SHAPE MEMORY MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    10810041650051
    PMA / PMN Number
    K182390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE LOT HISTORY RECORDS AND ACCOMPANYING LOT RELEASE REPORTS IDENTIFIED NO QUALITY ISSUES RELATED TO DEVICE PERFORMANCE. A BENCHTOP INVESTIGATION COULD NOT OCCUR BECAUSE THE DEVICES REMAIN 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 AORTIC WALL DUE TO THE PREVIOUSLY IDENTIFIED VESSEL PERFORATION AND HIGH FLOW IN THE VICINITY OF THE VESSEL IT WAS DEPLOYED TO. THE PATIENT IS IN STABLE CONDITION AND NO CLINICAL SEQUELAE HAS BEEN REPORTED SINCE THE FOLLOW UP CT SCAN. 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. NOTE: TWO LOTS WERE USED DURING TREATMENT AND THERE IS ONLY SPACE ON THE 3500A FORM TO LIST EXPIRATION AND MANUFACTURING DATES FOR ONE LOT. BELOW IS THE COMPLETE INFORMATION FOR BOTH LOTS. F23092601U MANUFACTURE DATE: 10/02/2023, EXPIRATION DATE: 01/02/2027. F23100701U MANUFACTURE DATE: 10/24/2023, EXPIRATION DATE: 01/24/2027. SHAPE MEMORY MEDICAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THE DEVICES WERE BEING USED TO TREAT AN ENDOLEAK. AFTER INITIAL ACCESS, IT WAS OBSERVED VIA ANGIOGRAPHY THAT THERE WAS A PERFORATION IN THE AORTIC WALL CAUSED BY THE BENTSON WIRE BEING USED. 70 IMP-FX-12 PLUGS WERE THEN DELIVERED, AND IT WAS NOTED THE PERFORATION APPEARED TO HAVE RESOLVED WITH THE DELIVERY OF THE IMPEDE-FX DEVICES. THE REMAINDER OF THE CASE WAS UNEVENTFUL, AND NO ABNORMALITIES WERE NOTICED DURING IMAGING. THE PATIENT REPORTED HAVING LOWER LEFT QUADRANT PAIN AND MALAISE POST-OPERATION. A FOLLOW UP CT WAS CONDUCTED IN RESPONSE TO THE LLQ PAIN, WHICH HAD IMPROVED BUT HAD NOT ENTIRELY RESOLVED SINCE THE PROCEDURE. DURING THE CT, IT WAS OBSERVED THAT SEVERAL IMP-FX-12 PLUGS (APPROXIMATELY 5-10) HAD MIGRATED OUTSIDE OF THE AORTIC WALL. THERE WAS NO INTERVENTION TO ADDRESS THE MIGRATED PLUGS AND THE LATEST UPDATE IS THAT THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401001 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE, PRODUCT CODE: KRD KRD SHAPE MEMORY MEDICAL INC. IMP-FX-12 F23092601U, F23100701U 10810041650051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other STENT GRAFT. MFG/MODEL UNKNOWN.