Catalog Number IGTCFS-65-1-FEM-CELECT-PT |
Device Problems
Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Perforation of Vessels (2135); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog #: unknown but referred to as a cook celect filter.Expiration date: unknown as lot # is unknown.Since catalog # is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date unknown as lot # is unknown.Investigation is still in progress.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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(b)(4).Catalog#: igtcfs-65-1-fem-celect-pt (b)(4).According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving warranting supplementation in accordance with 21 c.F.R.803.56.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2016." patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
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Event Description
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This additional information was received on 01/13/2017 as follows: the patient allegedly received device implant via right femoral vein on (b)(6) 2016 to prevent blood clots.The patient alleges that the device is unable to be retrieved, chest pains, and anxiety after implant of device.
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Manufacturer Narrative
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Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer reference # (b)(4).Corrected data: adverse event to product problem.Serious injury to malfunction.It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating: "blood clots, device is unable to be retrieved, chest pains, anxiety".Cook will reopen its investigation if further information is received.Unknown if the reported chest pains and anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.A reference is made to the instructions for use: in potential adverse events are mentioned: damage to the vena cava; pulmonary embolism; filter embolization; vena cava perforation; vena cava occlusion or thrombosis; hematoma at vascular access site; hemorrhage; infection at vascular access site; death.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.
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Event Description
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Patient further alleges vena cava perforation.Report from ct (computed tomography): "inferior vena cava filter present.The struts extend outside the caval wall.The anterior straw abuts the duodenal sweep.".
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Manufacturer Narrative
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H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc) perforation the reported allegations have been further investigated based on the information provided to date.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This 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.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.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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