Manufacturer ref# (b)(4).4 catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.(b)(4).Summary of investigational findings: the reported allegations have been investigated based on the information provided to date.A filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Vena cava wall penetration/perforation has been reported and may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Unknown if the reported pain post implant and enterovenous fistula between ivc and duodenum 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 and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Cook medical will continue to monitor for similar events.
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Description of event according to initial reporter: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011.Alleged death, embedment, perforation and enterovenous fistula between ivc and duodenum.Patient death on (b)(6) 2016".Patient outcome: alleged "pain post implant, and enterovenous fistula between ivc and duodenum." patient is deceased.
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