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| Catalog Number UNKNOWN |
| Device Problems
Fracture (1260); Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907); Insufficient Information (3190)
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| Patient Problems
Dyspnea (1816); Thrombus (2101); Perforation of Vessels (2135); Stenosis (2263); Obstruction/Occlusion (2422); No Information (3190); No Code Available (3191)
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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.Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.(b)(4).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) 2011." 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#: unknown but referred to as a cook celect filter.Since catalog# is unknown the 510(k) could be either k061815, k073374 or k090140.(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 according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2011." 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 received on 02/08/2017 as follows: plaintiff was allegedly treated for blood clots and claims to have received an implant on (b)(6) 2011.Plaintiff is alleging vena cava perforation, device fracture and that the device is unable to be retrieved.Plaintiff alleges blood clots and shortness of breath due to device implant.
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Manufacturer Narrative
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(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: " plaintiff is alleging vena cava perforation, device fracture and that the device is unable to be retrieved.Plaintiff alleges blood clots and shortness of breath due to device implant.".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter fracture is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Fracture of a filter leg can be due to repetitive motion on a filter leg in an unusual stressed position.Among other causes, filter fracture may be associated with a filter leg perforating the ivc, a filter leg being caught in a side branch (e.G.Renal vein), 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.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Fracture of the wire is a known risk in relation to an implanted filter and reported in the published scientific literature.It is known from the published scientific literature that filter fragment embolized into the heart or lung may be safely retrieved.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.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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Per a report from retrieval report (successful); ¿occluded/stenosed inferior vena cava beginning at the level of the mid ivc just below the right renal vein and extending caudally including the bilateral iliac/femoral venous stents with large right abdominal and lumbar collaterals.Successful removal of a retrievable infrarenal cook celect ivc filter under fluoroscopic guidance.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: b1, b2, b5, b6, d6b, annex e, annex g, annex b, annex c, annex d, and h6.Investigation: the following allegations have been investigated: occluded/stenosed.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.Catalog number and lot number are unknown; however, the alleged filter is manufactured and inspected according to controls.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 becomes 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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