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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
Thrombus (2101); Patient Problem/Medical Problem (2688)
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Event Date 07/29/2019 |
Event Type
Injury
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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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Event Description
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Physician used venaseal closure system to treat the great saphenous vein (gsv), 28cm segment treated.Approximately 0.6-0.8ml of adhesive was used.It was reported that the vein closed, and the procedure was completed per the ifu.The lumen was flushed prior to use and ifu was followed during, preparation, procedure and post- procedure.It was reported that 48 hours post procedure, scan showed grade two thrombus extension.The patient has been described eliquis and is reported to be stable.
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Manufacturer Narrative
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Image review: four photographs of sonographic images were received for evaluation.Image 1 is an annotated longitudinal scan in the area of the saphenofemoral junction, (sfj).The locations of the sfj and the adhesive (¿glue¿) are annotated on the scan.Image 2 is a cropped enlargement of image 2.Due to the quality and clarity of the image it is not possible to positively determine if thrombus is present or not.Image 3 is a transverse, (cross section), scan of the sfj.A reflective mass in the great saphenous vein is visible.Due to the quality and clarity of the image the reflective mass may or may not be thrombus.Image 4 is an annotated longitudinal scan just proximal of the sfj.A reflective mass in the great saphenous vein is visible.Due to the quality and clarity of the image the reflective mass may or may not be thrombus.Image 5 is a transverse, scan of the sfj.A reflective mass is visible in the great saphenous vein between the two computer colored renderings.Due to the quality and clarity of the image the reflective mass may or may not be thrombus.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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