BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 8873965 · Received August 8, 2019

    Report

    Report Number
    9612164-2019-03288
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    August 2, 2019
    Report Date
    September 18, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    ADDITIONAL INFORMATION: THE PATIENT IS REPORTED TO BE DOING FINE AND NO FURTHER TREATMENT HAS BEEN REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    THE CATHETER TIP WAS 5CM CAUDAL TO THE SAPHENO FEMORAL JUNCTION (SFJ) PRIOR TO DELIVERY OF ADHESIVE. PATIENT IS ASYMPTOMATIC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT HAD TREATED GREAT SAPHENOUS VEIN (GSV) TREATED WITH VENASEAL. IFU WAS FOLLOWED. PROCEDURE COMPLETED WITHOUT INCIDENT. POST PROCEDURE, PATIENT REPORTED MILD PHLEBITIS. ULTRASOUND REVEALED EVIDENCE OF NON-OCCLUSIVE THROMBUS IN THE SAPHENO FEMORAL JUNCTION (SFJ). PATIENT PRESCRIBED ANTI-PLATELET. PATIENT DUE FOR FOLLOW-UP IN 1-2 WEEKS. IF ISSUE PERSISTS WILL PRESCRIBE 325 MG ASA AND AN ANTICOAGULANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668220 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention