Model Number N/A |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Insufficient Information (3190)
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Patient Problems
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).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) 2009 at (b)(6) medical center in (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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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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It is alleged that the received "a gunther tulip filter on (b)(6) 2009 at (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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The event is currently under investigation.A supplemental report will be provided upon conclusion.(b)(4).
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Event Description
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This additional information was received on (b)(6) 2017 as follows: the plaintiff allegedly received device implant via the right femoral vein due to deep vein thrombosis and pulmonary embolism while on anticoagulation.Plaintiff alleges device tilt and vena cava perforation.
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Manufacturer Narrative
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Evaluation- 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 tilt and vena cava perforation".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Filter tilt is a known potential complication of vena cava filters.Among other causes, filter tilt may be associated with 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 procedure in the vicinity of a filter) and (or) procedures that involve devices passing through a filter, or a failed retrieval attempt.Excessive filter tilt may result in loss of filter efficiency.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature.Filter tilt may happen during placement or during implanting period.Filter perforation of the vena cava wall is a known risk reported in the published scientific literature.Also, published scientific literature describes that manipulation in the area of filter placement could contribute to changes to the filter configuration and placement thereby potentially initiate perforation of the vena cava wall.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.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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Search Alerts/Recalls
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