Catalog Number IGTCFS-65-FEM |
Device Problems
Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Issue (2379); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Thrombus (2101); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/23/2014 |
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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The patient received a gunther tulip filter on (b)(6) 2006 at an unnamed hospital in (b)(6).Plaintiff has not named an implanting physician.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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Manufacturer Narrative
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(b)(4).Corrected data based on new information received: updated attorney name adverse event to product malfunction 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 was received on (b)(6) 2016 as follows: plaintiff allegedly received an implant on (b)(6) 2006 via the femoral vein due to pulmonary embolism and dvt.Plaintiff is alleging migration, leg swelling of lower extremities.Date of attempted retrieval is unclear.
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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 "pt suffers from vena cava perforation, the inability to retrieve the device, and other: straightening of hook during removal attempt" cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.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.From the published scientific literature filter tilt inside ivc and/or embedment of filter legs or filter hook in the ivc wall is a well-known risk.Several case reports published in articles, describe successful retrievals of such filters by advanced retrieval techniques.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.
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Manufacturer Narrative
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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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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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This additional information received on 27/jul/2017 as follows: patient received an implant on (b)(6) 2006 via the right common femoral vein due to pulmonary embolism.Patient is alleging migration, leg swelling of lower extremities.Retrieval was attempted on (b)(6) 2014.
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Search Alerts/Recalls
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