BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8045310 · Received November 7, 2018

    Report

    Report Number
    9612164-2018-03084
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENTS FROM THE VENASEAL CLOSURE SYSTEM KIT WAS RECEIVED FOR EVALUATION. THREE SONOGRAPHIC IMAGES OF THE PATIENT¿S SAPHENOFEMORAL JUNCTION WERE RECEIVED. TWO OF THE IMAGES SHOW A THROMBOSIS FORMATION EXTENDING INTO THE SAPHENOFEMORAL JUNCTION(SFJ). THE THIRD IMAGE SHOWS THE THROMBOSIS FORMATION RETREATED INTO THE GREAT SAPHENOUS VEIN (GSV). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED WITH VENASEAL, THE PROCEDURE WENT AS PLANNED AND WAS PERFORMED WITHOUT INCIDENT. THE CATHETER TIP WAS SEEN CLEARLY 5CM CAUDAL TO THE SAPHENO FEMORAL JUNCTION (SFJ) PRIOR TO DELIVERY OF ADHESIVE. COMPRESSION WAS USED. IT WAS REPORTED THE PATIENT RETURNED TO THE FACILITY FOR AN ULTRASOUND SCAN 6 DAYS POST PROCEDURE WHERE A THROMBUS EXTENSION WAS OBSERVED. THE PATIENT WAS PRESCRIBED BLOOD THINNERS EQUILIS (5MGS X 2 DAILY) FOR 10 DAYS. PATIENT RETURNED FOR SECOND FOLLOW-UP, IT IS REPORTED THE EXTENSION HAS RECEDED AND IS NOW WITHIN GSV AND NOT EXTENDING OUT INTO THE COMMON FEMORAL. PATIENT WILL FINISH 10 DAY RX OF ELIQUIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885813 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND 51909

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention