BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENA SEAL CLOSURE SYSTEM

    MDR report key: 23450197 · Received November 3, 2025

    Report

    Report Number
    9612164-2025-05373
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A PROCEDURE USING THE CLOSURE SYSTEM VS-404 VENASEAL US EA, A PATIENT DEVELOPED HYPERSENSITIVITY REACTIONS, PAIN, REDNESS, ITCHING, SKIN IRRITATION, AND RASH ALONG THE TREATED LEFT GREAT SAPHENOUS VEIN (PROXIMAL, MID, AND DISTAL SEGMENTS). THE SYMPTOMS APPEARED WITHIN 2 TO 14 DAYS AFTER THE PROCEDURE AND WERE PERSISTENT AND RECURRENT AFTER INITIAL IMPROVEMENT. MEDICAL INTERVENTIONS INCLUDED MULTIPLE DOSES OF STEROIDS (MEDROL DOSE PACK AND PREDNISONE), MOTRIN, BENADRYL, AND BACTRIM DS. POST FOLLOW UP ON (B)(6) 2025 DEVELOPED REDNESS, GIVEN MOTRIN/BENADRYL, PATIENT COMPLAINED OF ITCHING AND REDNESS ON (B)(6) 2025, PRESCRIBED BACTRIM DS, BID 7 DAY COURSE, AND MEDROL DOSE PACK 60MG TAPERED. FROM ON (B)(6), PATIENT STARTED FEELING BETTER. PATIENT WENT OFF MEDS, ITCHING RE-APPEARED ON (B)(6)2025 AND WAS PRESCRIBED 2ND DOSE BACTRIM DS, BID FOR 7 DAYS & MEDROL DOSE PACK TAPERED 60MG ON (B)(6) 2025. PATIENTS SYMPTOMS WERE PERSISTENT AND WAS PRESCRIBED PREDNISONE 20MG DAILY ON (B)(6) 2025. PATIENTS PAIN AND REDNESS IS REPORTED TO HAVE GONE ON (B)(6) 2025 AND DOSAGE OF PREDNISONE WAS DECREASED TO 10MG DAILY ON (B)(6) 2025 AND DOSAGE MAY BE DECREASED TO 5MG AND WILL BE THEN TAPERED OFF PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799135 VENA SEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention