BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7180870 · Received January 10, 2018

    Report

    Report Number
    9612164-2018-00051
    Event Type
    Injury
    Date Received
    January 10, 2018
    Date of Event
    December 11, 2017
    Report Date
    January 10, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENTS FROM THE VENASEAL CLOSURE SYSTEM KIT WAS RECEIVED FOR EVALUATION. NO PHOTOGRAPHIC IMAGES OF THE PATIENT¿S SYMPTOMS WERE RECEIVED FOR EVALUATION. FOUR PHOTOGRAPHIC IMAGES OF SONOGRAM IMAGES WERE PROVIDED. THE IMAGES SHOW A POSSIBLE THROMBOSIS/ADHESIVE MASS PROTRUDING INTO THE SAPHENO-FEMORAL JUNCTION. CUSTOMER EXPERIENCE IS CONFIRMED BASED ON PHOTOGRAPHS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED VENA SEAL TREATMENT OF THE LEFT AND RIGHT GREAT SAPHENOUS VEIN (GSV). PROCEDURE WAS COMPLETED AS PER IFU AND STANDARD PROTOCOLS. CATHETER TIP WAS LOCATED 5CM CAUDAL TO THE SAPHENO-FEMORAL JUNCTION (SFJ) PRIOR TO INITIAL DELIVERY OF THE ADHESIVE. VOLUMES USED WERE REPORTED AS 1.5CC IN LEFT GSV <(>&<)> 1.2CC IN RIGHT GSV. THE TOTAL LENGTHS TREATED WERE REPORTED AS 38CM LEFT GSV, 32CM IN RIGHT GSV. IT WAS REPORTED THAT THE VEIN CLOSED. ON ULTRASOUND CHECK, 2 DAYS POST PROCEDURE, IT COULD BE SEEN THAT THE GLUE PROTRUDED PAST THE SFJ. IT IS REPORTED THAT THE PATIENT WAS PRESCRIBED XARELTO DUE TO PROTRUSION OF THE GLUE. THE PATIENT IS REPORTED TO BE DOING WELL. FOLLOW-UP INFORMATION INDICATES THE PATIENT HAD A MILD INFLAMMATORY RESPONSE, HOWEVER FOLLOW-UP ULTRASOUND INDICATES THAT THE PROTRUSION HAS RETRACTED DISTAL TO THE SFJ. THE PHYSICIAN PLANS TO CONTINUE WITH XARELTO FOR A FULL COURSE OF 12 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22832 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention