WILLIAM COOK EUROPE COOK CELECT JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-JUG-CELECT-PERM |
Device Problems
Inadequate Filtration Process (2308); Structural Problem (2506); Insufficient Information (3190)
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Patient Problems
Pulmonary Embolism (1498); Death (1802); Perforation of Vessels (2135)
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Event Type
Death
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook celect filter.Occupation: non-healthcare professional.Investigation is still in progress.
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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: patient is deceased.
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Manufacturer Narrative
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Additional information: the following field was updated per additional information received: adverse event problem.Investigation ¿ investigation is reopened due to additional information provided.The following allegations have been investigated.Wrongful death.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported wrongful death is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, there is 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 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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.
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Event Description
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No additional information provided at this time.
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Event Description
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Patient allegedly received an implant on 15jun2009 via the right internal jugular vein due to combination deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging vena cava perforation, organ perforation (aorta), pe post implant causing death.It is further alleged "[patient] would also experience anxiety, mental anguish and stress about the status of [the] filter and any related injuries," as well as physical limitations, worry, and severe pain and numbness in legs.On (b)(6) 2017, report from ct (computed tomography): "the ivc filter is in place.The proximal tip is at the level of the inferior margin of the right renal vein, well centered in the ivc.Several of the struts perforate the wall with one strut seen just anterior to the aorta, abutting the aorta but not perforating (series 2 image 33); strut just posterior to the aorta, abutting but not perforating (series 2 images 29-31); anterior strut perforating and protruding through the third portion of the duodenum (series 2 images 31-33); however, with no surrounding fluid or fat stranding.Finally, fourth lateral struts perforating the lateral ivc wall into the surrounding fat.Aorta is of normal caliber."
06jul2019, certificate of death: immediate cause of death - pulmonary embolism; underlying cause: blood infection, blood clots.Significant conditions contributing to death but not resulting in the underlying cause: heart valve repairs.
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Manufacturer Narrative
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Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: pulmonary embolism, organ/vena cava perforation, anxiety, mental anguish, stress, physical limitations, pain, numbness and worry.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.Unknown if the reported anxiety, mental anguish, stress, physical limitations pain, numbness and worry are directly related to the filter and unable to identify a corresponding failure mode at this point in time.10 devices in lot.No relevant notes on work order.The product is manufactured and inspected according to specifications.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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