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Catalog Number VS-404 |
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 03/27/2024 |
Event Type
malfunction
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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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Event Description
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On 08-mar-2024 a physician used a venaseal closure system during treatment of a soft tissue lesion in the patients right mid artery/vein.Lesion length reported as 200mm.Artery/vein diameter reported as 5mm.There were no abnormalities reported in relation to anatomy.It was reported patient developed an egit near the sfj after venaseal procedure.Reported under ultrasound on follow up.The onset of symptoms occurred between days 2-14 after procedure.There are no known patient allergies.There are no known co-morbidities.No medical or surgical intervention was required and the issue is still present.
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Manufacturer Narrative
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Product analysis cyanoacrylate (venaseal) glue extension (egit or arte) noted in images to the left ¿ noted with yellow highlight.No definitive measurement of length of size of egit can be made definitive location of saphenous junction not made, but estimated with right edge of yellow highlight to image a cross sectional view would aid in identification of the % stenosis this ¿extension¿ is causing in the femoral vein 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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