BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 9669589 · Received February 5, 2020

    Report

    Report Number
    9612164-2020-00560
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 27, 2020
    Report Date
    March 31, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PATIENT IS DOING WELL AND IS BEING MONITORED. THE PHYSICIAN ESTIMATES THAT NO FURTHER ACTION WILL BE REQUIRED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: THREE CINES WERE RECEIVED FOR EVALUATION. PER THE CINES, IT WAS OBSERVED "THROMBUS EXTENSION¿ INTO THE DEEP SYSTEM OF THE GSV. 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

    PATIENT RECEIVED VENASEAL TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). IFU WAS FOLLOWED.1 SEGMENT WAS TREATED, AND THE VEIN IS REPORTED TO HAVE CLOSED. AN ULTRASOUND CARRIED OUT ONE-WEEK POST PROCEDURE SHOWED A CLASS 2 NON-OCCLUSIVE THROMBUS DISTAL TO THE COMMON FEMORAL JUNCTION (CFJ). PATIENT WAS PRESCRIBED XARELTO FOR 3 MONTHS. THE PHYSICIAN BELIEVES THIS MAY NOT BE DUE TO VENASEAL MIGRATION AS ULTRASOUND WAS COMPARED WITH IMAGES WHICH WERE TAKEN RIGHT AFTER THE PROCEDURE WHICH SHOW THAT CFJ WAS CLEAR OF ANY THROMBUS OR FOREIGN BODY. NO FURTHER PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134567 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention