BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 12049038 · Received June 23, 2021

    Report

    Report Number
    9612164-2021-02439
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    October 26, 2020
    Report Date
    June 23, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    UDI-DI
    00643169986268
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: FOUR POST-PROCEDURE PHOTOGRAPHS OF POST-PROCEDURAL IMAGES WERE RECEIVED FOR REVIEW. THE FIRST TWO IMAGES ARE OF THE PATIENT¿S RIGHT LOWER TREATED LIMB SHORT SAPHENOUS VEIN, (SSV) APPROXIMATELY 6.5 MONTHS POST PROCEDURE. REFLECTIVE MASSES ARE VISIBLE WITHIN THE RIGHT SHORT SAPHENOUS VEIN. THE LAST TWO IMAGES ARE OF THE PATIENTS LEFT TREATED LIMB GREAT SAPHENOUS VEIN, (GSV). REFLECTIVE MASSES ARE VISIBLE WITHIN THE TREATED LEFT GREAT SAPHENOUS VEIN. MEDICAL AFFAIRS WAS CONTACTED FOR REVIEW OF THE IMAGES. THE IMAGES WERE DETERMINED TO ABNORMAL FOR A VENASEAL CASE. THERE APPEARS TO BE A MASS SURROUNDING THE SSV SEGMENT AND ADJACENT TO THE VEIN IN THE GSV. THE MASSES MAY BE A FOREIGN BODY GRANULOMA FORMATION, OR A MIXED ECHOGENICITY FLUID FILLED MASS WHICH COULD BE ASCERTAINED WITH A HISTOLOGIC EXAMINATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PHYSICIAN USED A VENASEAL CLOSURE SYSTEM TO TREAT A PATIENT¿S GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV). THE RIGHT LEG WAS INITIALLY TREATED, FOLLOWED BY THE LEFT 1 DAY LATER. THE IFU WAS NOT FOLLOWED, DID NOT USE BLUE SHEATH. NO GUIDEWIRE USED FOR THE INSERTION OF THE CATHETER. NO COMPRESSION USED. TUMESCENT INFILTRATION WAS NOT UTILIZED. LOCAL ANAESTHESIA WAS USED. THERE WERE NO ISSUES DURING PROCEDURE. 2 SEGMENTS WERE TREATED, AND THE VEIN IS REPORTED TO HAVE CLOSED. IT IS REPORTED THE PATIENT EXPERIENCED PAIN AROUND THE TREATED AREAS AFTER SIX MONTHS, NONE EXISTED BEFORE THEN. NO ADDITIONAL TREATMENT WAS CONDUCTED. ONE MONTH LATER THE PATIENT CAME IN FOR THEIR FOLLOW UP APPOINTMENT AND THE RIGHT SSV MIDCALF AND THE LEFT GSV PROXIMAL THIGH WERE OF CONCERN. THE PATIENT WAS COMPLAINING OF LEG PAIN AND KNOTS IN THESE AREAS. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT THE PATIENT IS IN NO PAIN AND DOES NOT REQUIRE ANY FURTHER TREATMENT. POST PROCEDURAL IMAGES WERE RECEIVED WHICH REVEALED MASSES WHICH MAY BE A FOREIGN BODY GRANULOMA FORMATION, OR A MIXED ECHOGENICITY FLUID FILLED MASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950056 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND VS-402 59260 00643169986268

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR