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Catalog Number UNKNOWN |
Device Problems
Occlusion Within Device (1423); Insufficient Information (3190)
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Patient Problems
Congestive Heart Failure (1783); Occlusion (1984); Swelling (2091); 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 the patient received a gunther tulip filter implanted on or about (b)(6) 2007.It is alleged that the plaintiff 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).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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This additional information received on 09feb2018 as follows: pt allegedly received an implant on (b)(6) 2007 via the right internal jugular vein due to history of left lower extremity deep venous thrombosis.Pt is alleging device is unable to be retrieved, occlusion of the ivc and bilateral iliac veins, underwent recannulization of the chronic occlusion, balloon angioplasty, and stent placement, failed retrieval attempt, severe swelling of the legs with congestive venous symptoms, venous collaterals along the abdominal wall and thoracic chest wall.Additionally the patient alleges extreme difficulty walking, congestive heart failure and diminished lung capacity.Retrieval was attempted (unsuccessful) on (b)(6) 2016.
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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, unable to retrieve, icv occlusion, leg swelling, difficulty walking, congestive heart failure'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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 difficulty walking, leg swelling, and congestive heart failure 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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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 ¿gunther tulip filter implanted".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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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