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COOK INC GUNTHER TULIP FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-FEM |
| Device Problems
Difficult to Remove (1528); Inadequate Filtration Process (2308); Obstruction of Flow (2423); Structural Problem (2506); Device Tipped Over (2589)
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| Patient Problems
Pulmonary Embolism (1498); Internal Organ Perforation (1987); Perforation of Vessels (2135); Anxiety (2328); Device Embedded In Tissue or Plaque (3165); Thrombosis/Thrombus (4440)
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Event Type
Injury
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Manufacturer Narrative
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Non-healthcare professional investigation the following allegations have been investigated: vena cava (vc)/aorta perforation, unable to remove.The reported allegations have been further investigated based on the information provided to date.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: trauma to adjacent structures, vascular trauma, vena cava perforation, vena cava penetration.Physician practice guidelines and published guidance from regulatory agencies recommend that patients with indwelling filters undergo routine follow-up.The risks/benefits of filter retrieval should be considered for each patient during follow-up.Once protection from pe is no longer necessary, filter retrieval should be considered.Filter retrieval should be attempted when feasible and clinically indicated.Filter retrieval is a patient-specific, clinically complex decision; the decision to remove a filter should be based on each patient¿s individual risk/benefit profile (e.G., a patient¿s continued need for protection from pe compared to their experience with and (or) ongoing risk of experiencing filter-related complications).For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.The filter is designed to be retrieved with the günther tulip vena cava filter retrieval set.It may also be retrieved with the cloversnare® vascular retriever.Cook has not performed testing to evaluate the safety or effectiveness of filter retrieval using other retrieval systems or techniques.The published clinical literature includes descriptions of alternative techniques for filter retrieval; use of these techniques varies according to physician experience, patient anatomy, and filter position.The safety or effectiveness of these alternative retrieval techniques has not been established.Specific for ¿embedded¿ a filter that is embedded in the wall of the ivc may be difficult to retrieve.For all retrievable ivc filters, retrieval becomes more challenging with time, and this is commonly due to encapsulation of the filter legs or hook (in a tilted filter) by tissue ingrowth.Catalog number and lot number are unknown.The alleged tulip is manufactured and inspected according to 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 medwatch report will be submitted if additional relevant information becomes available.
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Event Description
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The following information is alleged: the patient received a gunther tulip inferior vena cava (ivc) filter on (b)(6) 2007.The patient has experienced multiple perforation of the ivc , including a perforation of the aorta.In addition, the patient has undergone a failed attempted removal.Hospital and medical records have been requested, but not yet provided.
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Event Description
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No additional event information has been received since the last medwatch submission.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: the following allegations have been investigated: pulmonary embolism, and dvt.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.New pe as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: pulmonary embolism.Ivc occlusion/ thrombosis, new dvt, ivc stenosis as a reported complication, is a known risk in relation to filter implant and is well documented in the clinical literature and in clinical practice guidelines.This is supported by the clinical evidence report established to assess available clinical data to identify and evaluate the clinical safety and performance of the cook vena cava filters.Potential adverse events that may occur include, but are not limited to, the following: vena cava occlusion or thrombosis, vena cava stenosis, deep vein thrombosis.A total of 10 devices were manufactured in the reported lot.To date, one additional complaint has been reported against this lot.The associated work order was reviewed.No related/relevant notes were documented.The device 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.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 medwatch report will be submitted if additional relevant information becomes available.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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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The following fields were updated per additional information received: a2, a4, b5, b6, b7, d1, d4, d8, g4, h4, annex e, annex f, annex a, annex b, annex c, annex d, and h6.Investigation: the following allegations have been investigated: organ perforation, embedment, tilt, anxiety, worry.Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The additional information regarding organ perforation/embedment does not change the previous investigation results for vena cava perforation.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported anxiety and worry are directly related to the filter and unable to identify a corresponding failure mode at this point in time.10 devices in lot.No relevant notes on work order.The 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.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 medwatch report will be submitted if additional relevant information becomes available.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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Patient allegedly received an implant on (b)(6) 2007 due to deep vein thrombosis (dvt).The patient alleges organ and vena cava perforation.The patient also alleges embedment, prong perforated aorta, anxiety, worry, tilt, post implant pe and dvt.Patient underwent vascular surgery for attempted filter removal on (b)(6) 2018 due to filter embedded in posterior wall of the inferior vena cava.(b)(6) 2018, per a report from computed tomography; ¿positive for caval perforation.Superior extent of ivc filter inferior l2 vertebral body.Inferior extent superior l3 vertebral body.A total of 4 prongs have perforated the ivc.Maximum distance prongs perforated 6 mm.Coronal images 5 degree tilt left to right.Sagittal images 5 degree tilt posterior anterior.Diameter of ivc directly above filter 14 mm x 12 mm series 2 image 26"."a prong has perforated the aorta.".(b)(6) 2018, per a report from retrieval report (attempted); ¿tip well embedded in posterior wall of ivc with dense thick fibrotic tissue, unable to snare with clover or loop ivc filter immobile following loop capture and attempted sheath capture.#3.Venography confirmed a patent vena cava filter in it and exchange was made over the bentson wire to perform intravascular ultrasound.This similarly revealed a patent filter with good apposition of the feet.The tip appeared leaning against the wall of the posterior vena cava.¿.
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