| Catalog Number UNKNOWN |
| Device Problems
Difficult to Remove (1528); Unintended Movement (3026); Insufficient Information (3190)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook celect filter.(b)(4).Since catalog# is unknown 510(k) could be either k061815 or k073374.(b)(4).It has not been possible to investigate or evaluate this alleged 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 of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2009".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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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Corrected data based on new information received: adverse event to adverse event and product problem, serious injury to malfunction.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 received on 18/dec/2017 as follows: patient received an implant on (b)(6) 2009 via the right internal jugular vein due to gastric bypass surgery.Patient is alleging tilt, vena cava perforation, perforation grade 2 x5 and grade 3 x 1 and that the device is unable to be retrieved.
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Manufacturer Narrative
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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).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 'celect, tilt, vc perforation, ivc occlusion, unable to retrieve'.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.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.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.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.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.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 alleges embedment and deep vein thrombosis.Per venogram, (b)(6) 2013: " improved flow through the deep venous system and ivc filter but persistent irregularity and narrowing up into the filter from the common femoral vein.".
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Manufacturer Narrative
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Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Name and address for importer site: (b)(4).Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Additional information: investigation: investigation is reopened due to additional information provided.The reported allegations have been further 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.Unknown if the reported dvt is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalogue and lot# are unknown, but the celect filter is manufactured and inspected according to specifications.This report includes information known at this time.A follow up report will be submitted should 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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