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Lot Number 74138 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 04/04/2024 |
Event Type
Injury
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Event Description
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Physician used a venaseal closure system during treatment of patients right proximal great saphenous vein (gsv).Lesion exhibited 20% stenosis.There were no abnormalities reported in relation to anatomy.Physician accessed gsv twice during the procedure.Once at the ankle and once at the upper calf.Post procedure at follow-up ultrasound scan on 8 days post index egit/dvt was reported along the treated vein (>5cm from access site).The onset of symptoms occurred between days 2-14 after procedure.Thrombus was in the deep vein.The thrombus was extended from the sfj into common femoral vein filling approximately 20% of the cfv lumen.The issue is still present.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Additional information: there were no challenges or deviations related to the location of catheter tip prior to initial delivery of adhesive and the catheter tip was 5cm caudal to sfj.Compression of the gsv was applied.Patient was already on anticoagulation therapy, the dosage was increased, and the clot has started to retract at follow up scan.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.
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Search Alerts/Recalls
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