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Catalog Number VS-402 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Occlusion (1984); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/09/2016 |
Event Type
Injury
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Event Description
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The physician used a venaseal closure system during procedure of the great saphenous vein and the small saphenous vein.Approximately 85cm between both vessels were treated.At the conclusion of the procedure, no issues were identified.It was reported that 4 days post procedure the patient had a follow up ultrasound where it was noted that the common femoral vein was partially occluded.Further information supplied found that prior to initial delivery of adhesive the catheter tip was located 5cm from the junction.Additionally, compression was not held for the entire 3 minutes at the junction.The physician is monitoring the patient and has prescribed blood thinners.
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Manufacturer Narrative
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Two videos were provided for review - video 1 appears to be from a pre-treatment period.The thrombus extension is not apparent in this video.Video 2 is a post-treatment period in which the thrombus extension is seen extending into the common femoral vein.By a crude measurement the thrombus occludes the cfv by 41%, which warrants treatment by anticoagulation.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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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