BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 6041305 · Received October 19, 2016

    Report

    Report Number
    3011410703-2016-00019
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 23, 2016
    Report Date
    December 15, 2016
    Manufacturer
    COVIDIEN
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE VENASEAL CLOSURE SYSTEM WAS NOT RETURNED FOR EVALUATION. IMAGES WERE RECEIVED FROM CUSTOMER FOR EVALUATION. IMAGES 1 AND 2 ARE LONGITUDINAL IMAGES SHOWING A THROMBUS EXTENSION FROM THE SAPHENOFEMORAL JUNCTION INTO THE COMMON FEMORAL VEIN. IMAGE 3 IS A TRANSVERSE IMAGE OF THE SAPHENOFEMORAL JUNCTION SHOWING A THROMBUS EXTENSION INTO THE COMMON FEMORAL VEIN. IMAGE 4 IS AN IMAGE OF THE PROXIMAL GREAT SAPHENOUS VEIN SHOWING A NORMAL POST-TREATMENT RESULT WITH A NORMAL ¿STUMP¿. THE PATIENT WAS TREATED WITH ANTICOAGULATION MEDS AFTER THE THROMBUS EXTENSION WAS NO LONGER VISIBLE WHEN PRESENTED FOR SURGERY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN USED THE VENASEAL TO PERFORM A SCHEDULED PROCEDURE TO TREAT THE SAPHENO FEMORAL JUNCTION TO MID- CALF GREAT SAPHENOUS VEIN. IT WAS REPORTED A THROMBUS EXTENSION WAS DISCOVERED IMMEDIATELY FOLLOWING THE VENASEAL PROCEDURE. THE PHYSICIAN ELECTED TO PERFORM A LIGATION TO PREVENT ANY EMBOLIZATION. UPON GETTING THE PATIENT TO THE OPERATING THEATRE, THEY DISCOVERED THE EXTENSION WAS NO LONGER PRESENT NO SURGERY WAS PERFORMED. THE PATIENT WAS GIVEN ANTICOAGULATION MEDS. FURTHER INFORMATION RECEIVED: THE PATIENT SUFFERED A HYPERSENSITIVE RASH POST PROCEDURE AND WAS TREATED WITH STEROIDS. PATIENT IS FULLY RECOVERED AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693272 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ COVIDIEN VS-402 42356

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention