BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENASEAL CLOSURE SYSTEM

    MDR report key: 22357575 · Received June 30, 2025

    Report

    Report Number
    9612164-2025-03218
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    March 31, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PJQ
    PMA / PMN Number
    P140018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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 0474: AN IMAGE OF WHAT APPEARS TO BE A LIGATED VEIN NEAR THE GROIN. IMAGE 0475: A PATIENTS BILATERAL MEDIAL THIGHS MARKED AND ERYTHEMA NOTED ALONG MEDIAL THIGHS IN AREA OF GSV IMAGE 0476: A SINGLE IMAGE OF WHAT APPEARS TO BE EXCISED VEIN ON GAUZE. IMAGE 0477: AN EXCISED VEIN ON GUAZE. 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

    ADDITIONAL INFORMATION: THE CULTURE RESULT IS NEGATIVE (NO INFECTION). 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 ON (B)(6) 2025, THE GREAT SAPHENOUS VEIN (GSV) IN BOTH LEGS OF THE PATIENT WERE TREATED USING A VENASEAL CLOSURE SYSTEM AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE AVERAGE VESSEL DIAMETER WAS REPORTED AS 5.3MM. LOCAL ANESTHESIA WAS UTILIZED. THE VEINS WERE EFFECTIVELY OCCLUDED. ON (B)(6) 2025, POSTOPERATIVE EXAMINATION SHOWED NO FINDINGS. ON (B)(6) 2025, SUBCUTANEOUS INJECTION OF DUPILUMAB (EVERY 2 WEEKS) WAS INITIATED DUE TO SUDDEN ECZEMA OF UNKNOWN CAUSE AT THE DEPARTMENT OF DERMATOLOGY OF (B)(6) HOSPITAL. THE PRURITUS IMPROVED. THE PHYSICIAN BELIEVES THAT THE PATIENT'S SUDDEN ECZEMA WAS CAUSED BY THE PATIENT'S PAST HISTORY OF CHRONIC ECZEMA AND THAT IT IS DIFFERENT FROM THE GENERALIZED ALLERGIC SYMPTOMS AFTER TREATMENT WITH GLUE. ON (B)(6) 2025, FEVER, SWELLING AND PAIN IN THE INNER REGION OF BOTH THIGHS APPEARED. ON (B)(6) 2025, THE PATIENT CONSULTED (B)(6) HOSPITAL AND IT WAS DETERMINED THAT THE PATIENT HAD A TRANSIENT ALLERGIC REACTION AFTER THE SURGERY. THE FOLLOWING TREATMENT WAS PERFORMED. SKIN BIOPSY, DETAILED EXAMINATION BY THE INTERNAL MEDICINE DEPARTMENT, NORMAL ALLERGY, AND NO IMPROVEMENT DESPITE DISCONTINUATION OF ANTIHISTAMINE, WHICH WAS ALWAYS TAKEN ORALLY. INTERNAL USE: LOXOPROFEN, RABEPRAZOLE, FLOMOX, CELESTAMINE, CEFAZOLIN. ON (B)(6) 2025, SOL-CORTEF 500ML IV. ON (B)(6) 2025, SOL-CORTEF 100 MG IV. ON (B)(6) 2025, SLIGHT FEVER, HEAT SENSATION IN THE INNER SIDE OF BOTH THIGHS, PAIN CONTINUED BUT SHOWED SLIGHT IMPROVEMENT. ON (B)(6) 2025, FLUID APPEARED IN THE AFFECTED AREA, AND THE PATIENT COMPLAINED THAT THE PAIN WAS STILL SEVERE, SO WE DISCUSSED WITH THE PATIENT AND DECIDED TO REMOVE THE TREATED VEIN. ON (B)(6) 2025, EXTRACTION OF THE LEFT GSV WAS PERFORMED UNDER GENERAL ANESTHESIA. THE LEFT LEG, WHICH WAS IN SEVERE CONDITION (THE SKIN NEAR THE GROIN WAS INDWELLING, SELF-DESTRUCTION). AFTER CONFIRMING THAT THERE WAS NO GLUE NEAR THE JCT, THE SKIN WAS INCISED 2-3 CM ABOVE THE JCT. AFTERWARDS, LIGATION AND THE GSV DISSECTION. PHYSICIAN THEN MADE A SIMILAR INCISION ABOUT 10CM AWAY FROM THE PREVIOUS INCISION. PHYSICIAN CHECKED TO MAKE SURE THE STRIPPER WOULD NOT PASS THROUGH, AND IT DID NOT. BLOOD VESSEL A DHESIONS WERE STRONG AND COULD NOT BE REMOVED EVEN AFTER ATTEMPTING CLAUSE STRIPPING. THE INCISION SITE NEAR THE JCT AND THE 10CM SEPARATED INCISION SITE WERE CUT VERTICALLY AND CONNECTED. THERE WAS A YELLOW PUS IN THE INDWELLING REGION NEAR THE GROIN (ADIPOSE TISSUE?) SO, THE HARDENED TISSUE WAS PEELED OFF WITH AN ELECTRIC SCALPEL. FINDINGS OF INFLAMMATION MAINLY IN THE BLOOD VESSEL (GSV) WERE OBSERVED. ANOTHER INCISION WAS MADE IN THE 10CM PORTION. THE AREA AROUND THE GROIN REGION WAS THE STRONGEST INDURATION. TLA WAS PERFORMED BY REFERRING TO THE CASE OF PHYSICIAN REMOVAL. ECHO WAS UNABLE TO DETERMINE IF IT WAS SUBFASCIAL. PHYSICIAN CONTINUED TO EXFOLIATE HARDENED SUBCUTANEOUS TISSUE WITH AN ELECTRIC SCALPEL. AN ATTEMPT WAS MADE TO WITHDRAW THE BLOOD VESSEL FROM THE INCISION SITE, BUT IT WAS TORN OFF HALFWAY THROUGH. AN INCISION WAS MADE IN A PART 10CM APART FROM THE CURRENT INCISION. PUS/MELTED ADIPOSE TISSUE BEGAN TO DRIP OUT. PHYSICIAN REPEATED THE SAME OPERATION. ON THE 4TH INCISION, GLUE WAS NOT IN THE AREA AROUND THE KNEE, AND NORMAL GSV WAS EXPOSED. THE BLOOD VESSEL FILLED WITH GLUE WAS REMOVED. THE TREATMENT SITE WAS CAREFULLY CLEANED WITH SALINE. THE TREATMENT SITE WAS THEN SUTURED, AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS COMPLETED ONLY ON THE LEFT, TAKING INTO CONSIDERATION THE TREATMENT TIME AND PATIENT BURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837387 VENASEAL CLOSURE SYSTEM AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention