BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8163889 · Received December 14, 2018

    Report

    Report Number
    9612164-2018-03626
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    December 12, 2018
    Report Date
    March 19, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    IMAGE REVIEW A SINGLE PHOTOGRAPH OF A SONOGRAPHIC IMAGE WAS PROVIDED. THE SONOGRAPHIC IMAGE IS FROM THE AREA OF THE SAPHENOFEMORAL JUNCTION AND SHOWS A THROMBUS EXTENSION OF GREATER THAN 50% INDICATING THAT IT IS A LEVEL 3 EXTENSION. THE EVENT DESCRIPTION MENTIONS THAT THE PATIENT WAS PLACED ON ANTICOAGULANT THERAPY AND PRESCRIBE ZYRALTA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED A VENASEAL TO TREAT THE GREAT SAPHENOUS VEIN (GSV). THE IFU WAS FOLLOWED. LOCAL ANAESTHESIA AND HAND COMPRESSIONS WERE PERFORMED. THE PHYSICIAN WAS 5 CM AWAY FROM THE SAPHENOFEMORAL JUNCTION JUNCTION (SFJ) PRIOR TO TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED RESULTING IN VEIN CLOSURE. IT WAS REPORTED THAT A FOLLOW UP ULTRASOUND PERFORMED 48 HOURS AFTER PROCEDURE SHOWED A THROMBUS EXTENSION CLASS 3 IN THE SFJ. PATIENT HAD NO SYMPTOMS. ANTICOAGULANT THERAPY AND ZYRALTA WAS PRESCRIBED ALONG FOLLOW UP ULTRASOUND IN TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003632 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention