BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPEDE-FX EMBOLIZATION PLUG

    MDR report key: 18116437 · Received November 10, 2023

    Report

    Report Number
    3013353964-2023-00008
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    February 23, 2024
    Report Date
    March 8, 2024
    Manufacturer
    SHAPE MEMORY MEDICAL INC.
    Product Code
    KRD
    UDI-DI
    00810041650030
    PMA / PMN Number
    K181051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE VESSEL TREATED ON (B)(6) 2023 USED TWO SHAPE MEMORY MEDICAL DEVICES: IMP-07 AND IMP-FX-06. THE IMP-07 DEVICE DETAILS CAN BE FOUND IN THE FORM 3500A REPORT DATED 11/3/23.THIS SUPPLEMENTAL REPORT CONTAINS THE IMP-FX-06 DEVICE DETAILS. REVIEW OF THE IMP-FX-06 LOT HISTORY RECORD AND ACCOMPANYING LOT RELEASE REPORT IDENTIFIED NO QUALITY ISSUES RELATED TO DEVICE PERFORMANCE. ADDITIONALLY, REVIEW OF THE CASE IMAGES PROVIDED FROM THE FOLLOW-UP ON (B)(6) 2024 RETURNED NO FINDINGS. BASED ON THE INFORMATION RECEIVED THUS FAR, NO ROOT CAUSE CAN BE ATTRIBUTED TO THIS INCIDENT. SHAPE MEMORY MEDICAL COMPLAINT REFERENCE NUMBER: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    DURING TREATMENT OF AN AVM, RESIDUAL FLOW WAS REPORTED IN THE VESSEL WHERE AN IMP-07 DEVICE WAS IMPLANTED. THIS REQUIRED DELIVERY OF AN ADDITIONAL SHAPE MEMORY MEDICAL DEVICE, AN IMP-FX-06. NO ADVERSE EVENT TO THE PATIENT WAS REPORTED. A REVIEW OF THE LOT HISTORY RECORD AND ACCOMPANYING LOT RELEASE REPORT IDENTIFIED NO QUALITY ISSUES RELATED TO DEVICE PERFORMANCE. ADDITIONALLY, REVIEW OF THE CASE IMAGES PROVIDED FOUND THAT THE DEVICE WAS DEPLOYED AS INTENDED. BASED ON THE INFORMATION RECEIVED THUS FAR, NO ROOT CAUSE CAN BE ATTRIBUTED TO THIS INCIDENT. 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

    AN IMP-07 AND IMP-FX-06 DEVICE WERE USED IN A CASE IN (B)(6) TO TREAT AN AVM ON (B)(6) 2023. EMBOLIZATION WAS CONFIRMED AT THE END OF THE PROCEDURE. DURING A FOLLOW-UP VISIT ON (B)(6) 2024, IT WAS FOUND THAT THE VESSEL HAD RECANALIZED WHICH REQUIRED RE-INTERVENTION TO DELIVER ADDITIONAL EMBOLIC DEVICES (I.E., COOK NESTER COILS). THE PATIENT STATUS WAS REPORT STABLE.

    Description of Event or Problem · 0

    AN AVM IN THE ARM (APPROXIMATELY 3-5 MM DIAMETER) WAS BEING TREATED USING A COMBINATION OF SMM PRODUCTS. AFTER DEPLOYING AN IMP-07 TO THE 1ST VESSEL (4.65 MM DIAMETER), THE PHYSICIAN DEPLOYED AN IMP-05 DEVICE TO THE 2ND VESSEL (3.62 MM DIAMETER). FOLLOWING THIS, AN IMP-FX-06 WAS DELIVERED TO THE 3RD VESSEL (DIAMETER UNSPECIFIED). FIVE MINUTES AFTER THE IMP-FX-06 DEVICE WAS DEPLOYED, ANGIOGRAPHY CONFIRMED THE 2ND AND 3RD LESIONS HAD COMPLETELY EMBOLIZED; HOWEVER, BECAUSE RESIDUAL FLOW WAS STILL OBSERVED IN THE 1ST VESSEL, AN IMP-FX-06 DEVICE WAS DELIVERED TO THE SAME AREA AS THE IMP-07 DEVICE. THERE WAS "GOOD EMBOLIZATION POST-PROCEDURE" AND NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125605 IMPEDE-FX EMBOLIZATION PLUG VASCULAR EMBOLIZATION DEVICE KRD SHAPE MEMORY MEDICAL INC. IMP-FX-06 F21090201E 00810041650030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention