BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNUS CLOSURE

    MDR report key: 24781457 · Received April 3, 2026

    Report

    Report Number
    2183870-2026-00156
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    February 6, 2014
    Report Date
    April 28, 2026
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMAGE ANALYSIS A NUMBER OF IMAGES WERE PROVIDED FOR EVALUATION IN THE LITERATURE ARTICLE FIGURE 1. MRI OF CASE 1: TIBIAL AND SCIATIC NERVE INVOLVEMENT. A, AXIAL T2-WEIGHTED FAST SPIN ECHO (FSE) IMAGE WITH FAT SUPPRESSION AT THE LEVEL OF THE KNEE SHOWS A SUPERFICIAL DILATED VEIN (ASTERISK), REPRESENTING THE PRIMARY ABLATION SITE OF THE LSV. NOTE ENLARGEMENT AND T2 HYPERINTENSITY OF THE TIBIAL NERVE (ARROW) AND ITS BRANCH, THE MEDIAL SURAL CUTANEOUS NERVE (ARROWHEAD). THERE IS MILD DENERVATION CHANGE IN THE MEDIAL GASTROCNEMIUS MUSCLE (CROSS). B, AXIAL T2-WEIGHTED FSE IMAGE WITH FAT SUPPRESSION SLIGHTLY PROXIMAL TO (A) DEMONSTRATES IRREGULAR SOFT TISSUE (ARROWS) ADJACENT TO THE TIBIAL NERVE (ARROWHEAD), REPRESENTING THE ABLATED SCIATIC VEIN BRANCH. C, AXIAL T1-WEIGHTED SPOILED GRADIENT RECALLED ECHO (SPGR) IMAGE WITH FAT SUPPRESSION JUST PROXIMAL TO (B) SHOWS ENHANCEMENT OF THE SOFT TISSUE SURROUNDING THE PROXIMAL TIBIAL NERVE (ARROWS), CONSISTENT WITH INFLAMMATION AT THE SITE OF THE ABLATED VEIN. D, AXIAL T1-WEIGHTED SPGR IMAGE WITH FAT SUPPRESSION PROXIMAL TO (C) AT THE LEVEL OF THE SCIATIC BIFURCATION SHOWS ENHANCEMENT SURROUNDING THE NERVE (ARROWS). NOTE DILATED SCIATIC VEINS AT THE TERMINUS OF THE ABLATION (ARROWHEADS). FIGURE 2. INTRAOPERATIVE FINDINGS OF CASE 1. AYB, PREOPERATIVE APPROACH TO THE LESION IN THE POPLITEAL FOSSA. X IS THE SITE OF PERCUSSION TENDERNESS. C, THERMAL INJURIES OF SMALL SAPHENOUS VEIN WITH ANEURISMAL PORTION CORRESPONDING TO THE PALPABLE LESION. NOTE THE PROXIMITY OF THE PROXIMAL VENOUS LESION TO THE SCIATIC NERVE BIFURCATION. P INDICATES PERONEAL NERVE; S, SURAL NERVE; T, TIBIAL NERVE. D, FOCAL DISCOLORATION OF THE SCIATIC NERVE AT THE LEVEL OF THE BIFURCATION (ARROW) CONSISTENT WITH A BURN INJURY. EYF, BURN INJURIES OF THE TIBIAL AND PERONEAL NERVES. 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

    SCIATIC AND PERONEAL NERVE INJURIES AFTER ENDOVASCULAR ABLATION OF LOWER EXTREMITY VARICOSITIES COPYRIGHT * 2014 BY LIPPINCOTT WILLIAMS & WILKINS ISSN: 0148-7043/15/7401-0064 DOI: 10.1097/SAP.0000000000000193 B3 DATE OF PUBLICATION 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

    A 42-YEAR-OLD WOMAN PRESENTED WITH RIGHT LEG WEAKNESS IMMEDIATELY AFTER RADIOFREQUENCY ABLATION OF THE LSV FOR TREATMENT OF VARICOSITIES AND VENOUS INSUFFICIENCY BY A VASCULAR SURGEON. THE SURGERY INVOLVED A CUT-DOWN AT THE LATERAL ANKLE, INSERTION OF A 7-FRENCH VNUS RADIOFREQUENCY FIBER CATHETER, TUMESCENT ANESTHESIA ALONG THE LSV FROM THE DISTAL THIGH TO ANKLE UNDER ULTRASOUND GUIDANCE, TREATMENT AT 120-C, AND A TOTAL OF 45 CM OF VEIN WAS TREATED FROM THE DISTAL THIGH TO THE ANKLE IN 7-CM INCREMENTS. POSTOPERATIVELY, SHE COULD NOT MOVE HER RIGHT FOOT AND COULD NOT DORSIFLEX THE ANKLE. SHE EXPERIENCED PAIN IN THE POSTERIOR KNEE AND CALF AS WELL AS NUMBNESS IN THE FOOT EXTENDING TO THE THIGH. THE NUMBNESS IMPROVED IN A FEW DAYS BUT THE MOTOR WEAKNESS AND PAIN PERSISTED. EVALUATION AT THE TREATING OUTSIDE FACILITY INCLUDED AN EMG THAT REVEALED SEVERE RIGHT PERONEAL AND TIBIAL NEUROPATHIES. SHE BEGAN PHYSICAL THERAPY AND WAS FITTED WITH AN ANKLE-FOOT ORTHOSIS (AFO) FOR THE FOOT DROP. THE SENSORY DEFICITS CONTINUED TO IMPROVE, BUT THERE WAS NO MOTOR RECOVERY. THREE MONTHS LATER, THE PATIENT WAS THEN REFERRED TO OUR CLINIC FOR FURTHER EVALUATION OF HER LEG WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837542 VNUS CLOSURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Required Intervention