Model Number N/A |
Device Problems
Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Internal Organ Perforation (1987); Pain (1994); 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 cook gunther tulip on (b)(6) 2005.¿ it is alleged that 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 cook gunther tulip on (b)(6) 2005.¿ it is alleged that 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).Corrected data based on new information received: product problem, malfunction, corrected attorney information.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 09/08/2017 as follows: patient received an implant on (b)(6) 2005 via the right common femoral vein due to blood clots.Patient experiences legs of the filter protrude to the caval wall and extending into the retroparitoneal tissue.The left lateral strut extends through into the abdominal aorta.Patient is alleging pain and that the device is unable to be retrieved.
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Manufacturer Narrative
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Additional information: investigation - 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 'tulip, retroperitoneal, aorta, and vc perforation, unable to retrieve, pain'.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.Unknown if the reported pain is directly related to the filter and unable to identify corresponding failure mode(s) at this 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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Event Description
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Patient received an implant on (b)(6) 2005 via the right common femoral vein due to blood clots.The plaintiff alleges organ perforation, vena cava perforation, pain and that the device is unable to be retrieved.
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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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Patient received an implant on (b)(6) 2005 via the right common femoral vein due to blood clots.The plaintiff alleges organ perforation, vena cava perforation, pain and that the device is unable to be retrieved.
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Manufacturer Narrative
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Additional information: 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, "organ (retroperitoneal), aorta, and vc perforation; unable to retrieve, pain." 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.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.
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Search Alerts/Recalls
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