BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 7320917 · Received March 7, 2018

    Report

    Report Number
    9612164-2018-00469
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    January 1, 2017
    Report Date
    March 7, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: LITERATURE ARTICLE PUBLISHED DATE (YEAR ONLY VALID) ENDOVENOUS ABLATION USING VENASEAL SAPHEON CLOSURE SYSTEM FOR TREATMENT OF GREAT SAPHENOUS VEIN INCOMPETENCE SURGICAL PRACTICE (2017) SUPPL 1 PG 29 (P35) N/A. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS ABSTRACT AIMS TO ANALYZE THE RESULTS POST USE OF VENA SEAL IN PATIENTS WITH GSV INCOMPETENCE. THIS STUDY ENCOMPASSES CLINICAL EXAMINATION, DUPLEX ULTRASOUND AND PATIENT¿S SATISFACTION AND SYMPTOMS. SCORES WERE EVALUATED AT 6 WEEKS, 6 MONTHS AND 1 YEAR FOR 20 PATIENTS (27 LIMBS) TREATED WITH VENA SEAL. IT IS REPORTED TECHNICAL SUCCESS WAS 96%. TWO CASES DEVELOPED ERYTHEMA AND HEMATOMA AFTER OPERATION. NO MAJOR ADVERSE EFFECT OR COMPLICATION, INCLUDING DEEP VEIN THROMBOSIS WERE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164829 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention