BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8222280 · Received January 7, 2019

    Report

    Report Number
    9612164-2019-00084
    Event Type
    Death
    Date Received
    January 7, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 1, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    THE PATIENT PRESENTED WITH HEAVY BLEEDING, CHEST PAIN AND SEPSIS 3 DAYS PRIOR TO THE INDEX PROCEDURE. NITROGLYCERIN WAS ADMINISTERED. TRYPONIN LEVELS WERE ELEVATED. HEMOGLOBIN DROPPED FROM 10 TO 6. THE PATIENT EXPERIENCED A BRAIN BLEED/SUBDURAL HEMATOMA FROM THE LYTIC THERAPY AND DECEASED 2 DAYS POST INDEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT HAD A SUCCESSFUL VENASEAL PROCEDURE ON THE LEFT GREAT SAPHENOUS VEIN (GSV) FOLLOWED BY SCLEROTHERAPY. COMPRESSION WAS CARRIED OUT MANUALLY AND WITH TRANSDUCER. POST PROCEDURE, THE COMMON FEMORAL AND SAPHENOUS AT THE JUNCTION WERE COMPRESSIBLE. VENASEAL CLOSURE WAS NOTED BEGINNING APPROXIMATELY 4CM FROM THE SFJ WITH NO CLOT NOTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS/ LIGHT HEADEDNESS LATER THE SAME DAY OF THE PROCEDURE. PATIENT WAS EVALUATED DIAGNOSTICALLY, AND IT WAS DETERMINED THERE WAS A PULMONARY EMBOLISM LOCATED IN THE LEFT INFERIOR LOBAR PULMONARY ARTERY AND RIGHT MIDDLE LOBAR PULMONARY ARTERY. THE PATIENT IS CURRENTLY ON LYTIC THERAPY AND RECOVERY IS UNKNOWN AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14186 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R