BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 18727862 · Received February 16, 2024

    Report

    Report Number
    3013353964-2024-00002
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    February 8, 2024
    Report Date
    February 16, 2024
    Manufacturer
    SHAPE MEMORY MEDICAL INC.
    Product Code
    KRD
    PMA / PMN Number
    K182390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    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 COULD NOT OCCUR BECAUSE THE DEVICE REMAINED IMPLANTED IN THE PATIENT. BASED ON THE INFORMATION RECEIVED THUS FAR, NO ROOT CAUSE CAN DEFINITIVELY BE ATTRIBUTED TO THE DEVICE MIGRATION. ALTHOUGH, THE IMPEDE-FX EU 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 BELIEVED, BUT CANNOT BE CONFIRMED THAT THE DEVICE MAY HAVE MIGRATED DUE TO HIGH FLOW IN THE VICINITY OF THE VESSEL IT WAS DEPLOYED TO. NO ADVERSE EVENT TO THE PATIENT HAS BEEN REPORTED THUS FAR. HOWEVER, A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION BE RECEIVED FROM THE COMPLAINANT. 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 CHOOSING TO REPORT THIS INCIDENT TO FDA BECAUSE OF THE GENERAL SIMILARITIES BETWEEN THE TWO REGIONS. SHAPE MEMORY MEDICAL COMPLAINT REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    DURING TREATMENT OF A VARICOCELE, AN IMP-10 DEVICE AND TWO IMP-FX-12 DEVICES WERE DELIVERED TO THE RIGHT TESTICULAR VEIN. THIRTY SECONDS AFTER DEPLOYING THE SECOND IMP-FX-12 DEVICE, A FLUOROSCOPY SHOWED THE PLUG HAD MIGRATED TO THE RIGHT LATERAL PULMONARY SYSTEM. BECAUSE ATTEMPTS TO EXPLANT THE DEVICE WERE UNSUCCESSFUL, THE PHYSICIAN CHOSE TO LEAVE THE DEVICE AT THE LOCATION IT MIGRATED TO BECAUSE THE PLUG WAS IN A DISTAL LOCATION AND THE PATIENT STATUS WAS STABLE THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED 1 HOUR POST PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED THUS FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443672 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL INC. IMP-FX-12 F23052302U

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other