BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 9082104 · Received September 18, 2019

    Report

    Report Number
    9612164-2019-03969
    Event Type
    Injury
    Date Received
    September 18, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 22, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CATHETER TIP WAS POSITIONED 6CM FROM THE SFJ PRIOR TO INITIAL DELIVERY OF ADHESIVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PATIENT WAS DISCHARGED WITH ORAL ANTICOAGULATION. PATIENT IS REPORTED TO BE DOING WELL. PATIENT WILL REMAIN ON ORAL ANTICOAGULATION. 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 OCCLUDING DEVICE TO TREAT THE LEFT GREAT SAPHENOUS VEIN (GSV) SUCCESSFULLY, AND TWO DAYS POST PROCEDURE, PATIENT HAD A NORMAL FOLLOW UP. FIVE DAYS POST FOLLOW UP, PATIENT HAD ANOTHER VENASEAL PROCEDURE WITH THE TREATMENT OF THE RIGHT SHORT SAPHENOUS VEIN (SSV). TWO DAYS LATER, FOLLOW UP ULTRASOUND WAS NORMAL WITH THE EXCEPTION OF AND EHIT CLASS 1 AT THE LEFT SFJ. DAYS LATER, PATIENT WAS ADMITTED WITH BILATERAL DEEP VEIN THROMBOSIS (DVT) AND A SADDLE PULMONARY EMBOLUS. IT IS REPORTED THAT EHIT DEVELOPED INTO DEEP VEIN THROMBOSIS IN PATIENT. PATIENT IS IN HOSPITAL ON HEPARIN DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877180 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R