BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8854657 · Received August 2, 2019

    Report

    Report Number
    9612164-2019-03202
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 29, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW: FOUR PHOTOGRAPHS OF SONOGRAPHIC IMAGES WERE RECEIVED FOR EVALUATION. IMAGE 1 IS AN ANNOTATED LONGITUDINAL SCAN IN THE AREA OF THE SAPHENOFEMORAL JUNCTION, (SFJ). THE LOCATIONS OF THE SFJ AND THE ADHESIVE (¿GLUE¿) ARE ANNOTATED ON THE SCAN. IMAGE 2 IS A CROPPED ENLARGEMENT OF IMAGE 2. DUE TO THE QUALITY AND CLARITY OF THE IMAGE IT IS NOT POSSIBLE TO POSITIVELY DETERMINE IF THROMBUS IS PRESENT OR NOT. IMAGE 3 IS A TRANSVERSE, (CROSS SECTION), SCAN OF THE SFJ. A REFLECTIVE MASS IN THE GREAT SAPHENOUS VEIN IS VISIBLE. DUE TO THE QUALITY AND CLARITY OF THE IMAGE THE REFLECTIVE MASS MAY OR MAY NOT BE THROMBUS. IMAGE 4 IS AN ANNOTATED LONGITUDINAL SCAN JUST PROXIMAL OF THE SFJ. A REFLECTIVE MASS IN THE GREAT SAPHENOUS VEIN IS VISIBLE. DUE TO THE QUALITY AND CLARITY OF THE IMAGE THE REFLECTIVE MASS MAY OR MAY NOT BE THROMBUS. IMAGE 5 IS A TRANSVERSE, SCAN OF THE SFJ. A REFLECTIVE MASS IS VISIBLE IN THE GREAT SAPHENOUS VEIN BETWEEN THE TWO COMPUTER COLORED RENDERINGS. DUE TO THE QUALITY AND CLARITY OF THE IMAGE THE REFLECTIVE MASS MAY OR MAY NOT BE THROMBUS. 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

    PHYSICIAN USED VENASEAL CLOSURE SYSTEM TO TREAT THE GREAT SAPHENOUS VEIN (GSV), 28CM SEGMENT TREATED. APPROXIMATELY 0.6-0.8ML OF ADHESIVE WAS USED. IT WAS REPORTED THAT THE VEIN CLOSED, AND THE PROCEDURE WAS COMPLETED PER THE IFU. THE LUMEN WAS FLUSHED PRIOR TO USE AND IFU WAS FOLLOWED DURING, PREPARATION, PROCEDURE AND POST- PROCEDURE. IT WAS REPORTED THAT 48 HOURS POST PROCEDURE, SCAN SHOWED GRADE TWO THROMBUS EXTENSION. THE PATIENT HAS BEEN DESCRIBED ELIQUIS AND IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651315 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention