Model Number N/A |
Device Problems
Complete Blockage (1094); Insufficient Information (3190)
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Patient Problems
Atrial Fibrillation (1729); Occlusion (1984); Thrombosis (2100); 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.A supplemental report will be submitted upon completion.
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Event Description
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It is alleged that "[pt] received a cook gunther tulip on (b)(6) 2004.¿ 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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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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Manufacturer Narrative
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(b)(4).Corrected based on documentation provided by plaintiff's attorney.Selection corrected from no selection to product problem based on documentation provided by plaintiff's attorney.Selection corrected from no selection to serious injury based on documentation provided by plaintiff's attorney.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 (b)(6) 2017 as follows: plaintiff allegedly received an implant on (b)(6) 2004 via the right jugular vein due to a history of extensive pe, poor pulmonary reserve, and lower extremity dvt.Plaintiff is alleging that the ivc filter is chronically thrombosed, the ivc is occluded, atrial fibrillation, and abdominal pain.Records from implantation center do not provide any brand information (manufacturer, lot number, product code) to identify the ivc filter allegedly implanted.
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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 'ivc filter chronically thrombosed, ivc occluded, atrial fibrillation, abdominal pain'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Ivc thrombotic occlusion as an outcome for cook ivc filters is addressed in the published scientific literature.Ivc thrombotic occlusion is defined as the presence of an occluding thrombus in the ivc after filter insertion and documented by ultrasound (us), ct, mr imaging or venography; this may be symptomatic or asymptomatic.Unknown if the reported abdominal pain is directly related to the filter and unable to identify a corresponding failure mode 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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Search Alerts/Recalls
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