BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 21812404 · Received April 10, 2025

    Report

    Report Number
    9612164-2025-01855
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    November 27, 2024
    Report Date
    May 13, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS IMAGE IS A SINGLE IMAGE OF A PICTURE OF AN ULTRASOUND. IT IS LABELED LT CFV LONG. THE IMAGE SHOWS A LONGITUDINAL VIEW OF A VESSEL WITH WHAT APPEARS TO BE A FOREIGN SUBSTANCE IN THE VEIN. WITH A SINGLE IMAGE, ONE CANNOT SEE COLOR FLOW, THOUGH THIS DOES NOT APPEAR TO BE OCCLUSIVE.". MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENASEAL PROCEDURE ON HER PROXIMAL LEFT GREAT SAPHENOUS VEIN (GSV) AT ANOTHER PRACTICE ON (B)(6) 2024. PATIENT CAME TO (B)(6) ON (B)(6) 2024 FOR A SECOND OPINION AS SHE HAS INCREASED EDEMA WITH ASSOCIATED SENSITIVITY REACTION OF THE LEFT LOWER EXTREMITY. ULTRASOUND DEMONSTRATED PROPAGATION SO SHE WAS TRIALED ON ELIQUIX X 7 DAYS BY THE OTHER PRACTICE. PATIENT HAD INCREASED SWELLING TO HER FACE AND LIPS AND WAS RECOMMENDED BY THE OTHER PRACTICE TO STOP ELIQUIS AND TRANSITION TO PLAVIX. AN ULTRASOUND WAS PERFORMED BY (B)(6) AND WHAT APPEARS TO BE A VENASEAL GLUE EXTENSION WAS FOUND TO EXTEND INTO THE SFJ. (B)(6) PUT HER BACK ON ELIQUIS 5MG TWICE DAILY FOR 3 MONTHS AND ALSO A PREDNISONE 5MG TAPER PACK FOR 6 DAYS DUE TO MENTION OF A POSSIBLE SENSITIVITY REACTION INITIALLY AFTER THE PROCEDURE. PATIENT CAME FOR FOLLOW UP APPOINTMENT ON (B)(6) 2025 AND COMMUNICATED THAT SHE HAD ANOTHER ULTRASOUND ON (B)(6) 2024 THAT SHOWED A STABLE VENASEAL EXTENSION INTO THE SFJ. THE SFJ ALSO APPEARED TO REOPEN FROM MID THIGH TO ANKLE, WHICH WAS NOT NOTED ON THE PREVIOUS EXAM ON (B)(6) 2024. THE PATIENT CONTINUES TO COMPLAIN OF SWELLING IN HER LEGS AND HAS HEAVINESS IN BOTH HER LEGS. SHE ALSO HAS LEFT GROIN PAIN AND BELIEVES THE VENASEAL IS CAUSING IT. SHE FEELS HER SYMPTOMS ARE UNCHANGED SINCE THE PROCEDURE. THE PHYSICIAN EXPLAINED THAT IT IS POSSIBLE HER SYMPTOMS ARE NOT SECONDARY TO VENOUS PROBLEMS CONSIDERING IT HAS BEEN TREATED FOR THE MOST PART AND SHE HAD THE SAME SYMPTOMS WHEN THE GSV WAS NOTED TO BE CLOSED PRIOR TO IT BEING FOUND TO BE REOPENED DURING THE ULTRASOUND ON (B)(6) 2024. PHYSICIAN HAS PLANNED TO CONTINUE WITH ANTICOAGULATION AS A CAUTION AND CONTINUE WITH QUALITY GRADED COMPRESSION. PATIENT HAD REPEAT ULTRASOUND ON (B)(6) 2025 WITH NO CHANGES COMPARED TO THE PREVIOUS ULTRASOUND DONE ON (B)(6) 2024 AND THERE IS STILL WHAT APPEARS TO BE A STABLE VENASEAL EXTENSION INTO THE SFJ. PATIENT HAD A FOLLOW UP ON (B)(6) 2025 WITH PHYSICIAN AND HE REVIEWED WITH HER THAT THE FINDINGS WERE ESSENTIALLY STABLE AND DISCUSSED STOPPING ANTICOAGULATION WITH HER, BUT THE PATIENT DID NOT WANT TO DO THAT, SO HE RECOMMENDED DECREASING THE ELIQUIS DOSE FROM 5MG TO 2.5MG WHICH SHE WAS AMENDABLE TO THIS. THE PLAN IS TO CONTINUE WITH PROPHYLACTIC ANTICOAGULATION AND QUALITY GRADED COMPRESSION AND THEY WILL REPEAT ULTRASOUND IN 3 MONTHS AND WILL ALSO CONDUCT AN AORTOILIAC VENOUS DUPLEX AS WELL. THE PLAN IS TO CONTINUE WITH EVERY 3 MONTHS ULTRASOUND FOR AT LEAST A YEAR AND THERE ARE NO PLANS TO REMOVE THE GLUE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460081 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention