(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non-healthcare professional.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿tulip - tilt, vc perforation, pain, nausea, vomiting." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported pain is directly related to the filter.Unknown if the reported nausea and vomiting are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No evidence to suggest that this device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook gunther tulip filter on (b)(6) 2013".Patient allegedly received 2 implant filters on (b)(6) 2013 due to post deep vein thrombosis and pulmonary embolism.Patient outcome: patient alleges tilt and vena cava perforation.Patient further alleges "abdominal pain, nausea/vomiting, constant abdominal pain, chronic generalized pain".
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