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COOK INC GUNTHER TULIP JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Model Number N/A |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Insufficient Information (3190)
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| Patient Problems
Pulmonary Embolism (1498); Pain (1994); Thrombus (2101); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Pma/510(k) # k072240.The event is currently under investigation.
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Event Description
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It is alleged that the "patient received a gunther tulip filter on (b)(6) 2006 at (b)(6)." it is alleged that the patient was injured without further explanation.Patient is seeking punitive damages.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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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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It is alleged that the "patient received a gunther tulip filter on (b)(6) 2006 at (b)(6) medical center in (b)(6)." it is alleged that the patient 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 11/23/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right internal jugular vein due to deep vein thrombosis and pulmonary embolism.Plaintiff is alleging device is unable to be retrieved.Plaintiff alleges chest pain and blood clots due to device.
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Manufacturer Narrative
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(b)(4).Corrected data based on new information received: adverse event to product malfunction; serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.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.(b)(4).Corrected data based on new information received: adverse event to product malfunction; 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 11/23/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the right internal jugular vein due to deep vein thrombosis and pulmonary embolism.Plaintiff is alleging device is unable to be retrieved.Plaintiff alleges chest pain and blood clots due to device.
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Manufacturer Narrative
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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: device is unable to be retrieved, chest pain, blood clots.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Pe is a known risk in relation to filter implant reported in the published scientific literature.Also, it is reported that the pulmonary embolism in some cases may originate from upper extremities instead of lower extremity veins.With all filters, there is some risk of further pulmonary embolism.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.Unknown if the reported chest pain is 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.
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Manufacturer Narrative
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Investigation: the following allegations have been investigated: pulmonary embolism, vena cava (vc) perforation, migration, tilt, thrombus for previously reported blood clots, elevated heart rate, physical limitation.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe 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: pulmonary embolism.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.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported elevated heart rate and physical limitations 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.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Event Description
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In addition to the previous allegations, the patient alleges device migration, device tilt, vena cava perforation and pulmonary embolism (pe) post inferior vena cava (ivc) filter placement.Patient notes and further alleges experiencing "in (b)(6) 2011, i was diagnosed with more blood clots in both of my legs", elevated heart rate, and physical limitations.Per the (b)(6) 2019 computed tomography (ct) abdomen without contrast: "impression: 1.Abnormal position of ivc filter.2.Proximal ivc at l1-l2 disc space.Filter is tilted towards the right with the proximal end abutting the right ivc wall.Proximal filter is 4.4 cm caudad to the level of the renal arteries.Left anterior prong extends 7 mm beyond the ivc wall, image 57, arid extends posterior and closely adjacent to a vessel.Left posterior-lateral prong extends 6 mm beyond lateral ivc wall image 67, extending posterior to the abdominal aorta.No broken or displaced prongs.No fluid surrounding the prongs".
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Search Alerts/Recalls
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