BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7717455 · Received July 25, 2018

    Report

    Report Number
    9612164-2018-01849
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    July 12, 2018
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: APPROX 1.5CC OF CYANOACRYLATE WAS USED TO TREAT A 31 CM LENGTH. THE PATIENT CONTINUES TO DO WELL. THE PHYSICIAN ADDED THAT THE PATIENTS COAT PROFILE WAS POSITIVE FOR ELEVATED FACTOR VIII LEVELS AND HETEROZYGOUS MTHFR GENETICS- BOTH PUTTING HER AT INCREASED RISK OF DVT THE DEVICE WAS NOT RECEIVED FOR EVALUATION. SIX SONOGRAPHIC IMAGES WERE RECEIVED FOR EVALUATION OF THE SAPHENOFEMORAL JUNCTION (SFJ) AND GREAT SAPHENOUS VEIN (GSV). IMAGES 1 AND 2 (TIME STAMP AZ 07/12/2018 09:45:31AM) ARE CROSS SECTIONAL VIEWS SHOWING A THROMBOSIS FORMATION EXTENDING FROM THE GSV INTO THE SFJ. IMAGE 2 IS OF THE VESSEL ANATOMY UNDER COMPRESSION. IMAGES 3 AND 4 (TIME STAMP AZ 07/12/2018 09:43:46AM) ARE CROSS SECTIONAL VIEWS SHOWING A THROMBOSIS FORMATION IN THE SFJ. IMAGE 4 IS OF THE VESSEL ANATOMY UNDER COMPRESSION. IMAGE 5 (TIME STAMP AZ 07/12/2018 09:49:03AM) IS A LONGITUDINAL VIEW SHOWING A THROMBOSIS FORMATION EXTENDING FROM THE GSV INTO THE SFJ. IMAGE 6 (TIME STAMP AZ 07/12/2018 09:53:14AM) IS A LONGITUDINAL VIEW SHOWING A THROMBOSIS FORMATION EXTENDING FROM THE GSV INTO THE SFJ. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN USED THE VENASEAL TO SUCCESSFULLY TREAT THE RIGHT GREAT SAPHENOUS VEIN(GSV), AS PER IFU. IT WAS REPORTED THE PATIENT ATTENDED A SCAN 6 DAYS POST PROCEDURE. THE PATIENT PRESENTED WITH SEVERE PAIN IN THE TREATED LIMB AND WAS DIAGNOSED WITH PHLEBITIS. THE ULTRASOUND SHOWED AN EHIT (ENDOVENOUS HEAT INDUCED THROMBUS) CLASS 2. THE PATIENT WAS PRESCRIBED IBUPROFEN 600MG X3, DAILY AND TRAMADOL-50MG 1-2 TABS EVERY 6 HOURS OR WHEN NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561588 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 50655

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention