COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Model Number G33016 |
Device Problems
Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589); Unintended Movement (3026); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Cellulitis (1768); Fatigue (1849); Pain (1994); Thrombosis (2100); Perforation of Vessels (2135); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Manufacturer Narrative
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The previous mdr was submitted by william cook europe under manufacturer report reference# 3002808486-2019-00092.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial report, cook inc.Informs that all future submissions regarding this complaint will be handled under this manufacturer report reference #.(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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It was reported the patient allegedly received a gunther tulip filter implant on (b)(6) 2013 due to deep vein thrombosis and pulmonary embolism.The patient is alleging tilt, migration and deep vein thrombosis.The patient further alleges limited or no ability for strenuous manual labor, right toe cellulitis ((b)(6) 2015) toe amputation ((b)(6) 2015), and back pain.The filter was successfully removed (b)(6) 2015.Per the (b)(6) 2015, x-ray -spine lumbosacral 2 or 3 views: "there is an inferior vena cava filter which is tilted high in position tip is at t12 may be within the hepatic vein branches appear this filter needs to be repositioned or removed".Per the (b)(6) 2018, categorization form: "us le venous doppler showed deep vein thrombosis involving the left femoral and popliteal vein.".
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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 ¿migration, tilt, dvt, fatigue, cellulitis, toe amputation, and pain." cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.Unknown if the reported back pain is directly related to the filter.Unknown if the reported dvt, fatigue, cellulitis, and toe amputation are directly related to the filter and unable to identify a corresponding failure mode at this point in time.No other complaints on lot.Product is manufactured and inspected according to specifications.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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No additional information has been provided at this time.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: vena cava (vc) perforation.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: vascular trauma, vena cava perforation, vena cava penetration.A total of 20 devices were manufactured in the reported lot.To date, no other complaints have been reported against the lot.The associated work order was reviewed.No related/relevant notes were documented.The device is manufactured and inspected according to current controls.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Per an undated medical opinion: review of various imaging/dates: "positive for perforation (grade 2) and tilt, possible cephalad migration".
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Search Alerts/Recalls
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