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Additional information: venous insufficiency, prominent reticular and spider veins, and spider veins were noted prior to procedure.Procedural therapy was deemed medically necessary due to patient failing 3 months of trial of conservative therapy, vein symptoms, and has one of the following: recurrent episodes of superficial thombophlebitis, nonhealing ulcers, bleeding from a varicosity, stasis dermatitis or refractory dependent edema, no evidence of aneurysm in the target segment, maximum vein diameter of 12 mm for erfa and 20 mm for laser ablation, no evidence of thrombosis or vein tortuosity which would impair catheter placement, and an absence of significant peripheral arterial disease.Vein treated was mapped with duplex ultrasound in upright position.Patient then placed in appropriate position and area to be treated prepped with hibiclens solution and draped in sterile fashion.Access site anesthetized with 1 cc's of 1% lidocaine with epinephrine.Tumescent anesthesia administered to fascial planes surrounding vein treated, utilizing anesthesia pump with 22-gauge needle.Left great saphenous vein was treated.Access to vein obtained under ultrasound guidance with 22-gauge micro-introducer at level of the medial calf.5 fr, 10 cm sheath advanced with ultrasound guidance into incompetent vein.Once in position, adhesive released in incompetent vein and venaseal catheter slowly retracted along the entire length of the vein.Adhesive administered was 2.0ml.Doppler used on patient left leg and indicated venous insufficiency.Left lsv, spj, proximal gsv, mid gsv, distal gsv all had no reflux.Left leg doppler findings were normal.Left leg superficial veins doppler findings were competent gsv, lsv, and perforating veins.Left deep veins doppler finds were competent common femoral, popliteal, and posterior tibial veins.Pain was noted in the left anterior proximal thigh.Foreign reaction to venaseal was noted and anti-inflammation topically was prescribed.Arthritis pain (diclofenac) 1% topical gel tp was prescribed.Follow-up ultrasound post ablation noted left sfj patent, gsv closed proximal to thigh.Dvt reported negative.Physician planned 1 lesion injection of intralesional kenalog, 40.0mg/cc, with total of 1.0 cc injected.The risks of atrophy were r eviewed with patient and procedure was deemed medically necessary because lesions that were treated were inflamed and painful.Patient prescribed mupirocin 2% topical ointment tp.Spider veins, venous insufficiency and prominent reticular and spider veins noted on the left thigh.Doppler used on left leg for superficial and deep veins.No reflux noted.Doppler findings normal and competent for all veins.Venous compression 20-30 mmhg recommended.Patient presented to wound check with infection, doxycycline hyclate 100 mg capsule was prescribed.Mupirocin and optifoam applied to area.Wrapped from knee to mid-thigh with cotton and coban to keep on for 1 week.Reduced swelling and tenderness along length of treated gsv of left thigh interval reduction in swelling noted; however, two areas 1x1 cm and 3x1 m in length necrotic plaques noted.Skin infection nos noted bright red, warm, tender plaques distributed on the left medial proximal pretibial region.Dxd included skin infection, nox vs atypical mycobacterium.Diagnosed of other specified bacterial agents and foreign body reaction.Plan for biopsy by punch method on the left medial proximal pretibial region.Area prepped with alcohol.Local anesthesia obtained with approximately 2 cc fo 1% lidocaine with epinephrine.2 mm punch biopsy.Punch biopsy for tissue culture conducted on left medial proximal pretibial region.Area prepped with hibiclens and local anesthesia obtained with approximately 0.5 cc of 1% lidocaine with epinephrine.2 mm punch biopsy for tissue culture obtained from left medial proximal pretibial region.Debridement of wound tissue less than 20 sq cm performed.Following day, the wound was dressed.No major interval change from debridement of necrosis.Physician planned to continue doxy hyclate 100 mg po, have patient change bandage daily and apply gentamicin bid and then cover, bacterial cx done, and have prednisone 30 mg po taper.Reduction in swelling and tenderness along length of treated gsv of left thigh interval reduction in swelling noted; however, two areas 1 x 1 cm and 3 x 1 cm in length necrotic plaques.Physician prescribed gentamicin 0.1% topical ointment tp and prednisone 10 mg tablet po.Necrotic ulcers with eschar located on the left leg noted.Applied gentamicin bid to both affected areas.At one week follow up, fungal and bacterial infection noted.Physician prescribed doxycycline hyclate 100 mg capsule po.1.1 cm x 3 cm of the left anterior distal thigh with margin of 0.2 cm was treated with 1.5 x 3.4 cm excised with fusiform.Local infiltration of 1% lidocaine with epinephrine anesthesia used.Incisions were then made along these lines to appropriate tissue plane and lesion was extirpated.Lesion was excised to layer of the adipose tissue, removed and sent to pathology for processing and histologic evaluation.Complex repair was performed because closure of the subcutaneous tissue and superficial non-muscular fascia required, because damaged skin surrounding defect made closure difficult, because extensive undermining required, because inelasticity of skin made closure difficult, because burow's triangles were required, because stents or retention suture placement was necessary and to avoid a deforming, depressed, and contracted scar.Extensive wide undermining was performed.Extensive undermining was performed to a distance of 1.6 cm (defect width perpendicular to closure is 1.5 cm) along the edge of the entire surgical defect.Hemostasis was achieved with electrocautery.Subcutaenous tissue and ermis were closed with 4-0 monocryl.Lesion was excised was the most proximal.Epidermal closure was achieved with 4-0 ehtilon (bolstering).Retention sutures were placed to support the closure and prevent dehiscence.Final wound length was 3.5 cm.Bacitracin and dry sterile dressing were applied.Ulceration noted on the left anterior distal thigh with associated diagnosis of cutaenous pain.Fusiform excision was performed on the left anterior distal thigh with preop size of 1.9 cm x 1.7 cm with margin of 0.2 cm and the total excised diameter was 2.3 cm x 2.1 cm.Procedure was done same as previous with extensive undermining performed to distance of 1.8 cm (defect width perpendicular to closure of 1.7cm) and final wound length of 3.5 cm.Petrolatum and pressure dressing with telfa were applied.Fives post culture, no growth of aerobic bacteria culture noted on thigh.No fungal elements seen and no fungal growth at 3 weeks on left thigh noted.No further patient injury reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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Image review: the customer provided photos of reported lesions encountered by the patient.The photo shows the infected lesions and then through the different phases of treatment where the affected areas were cleaned and stitched.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
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