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WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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| Catalog Number IGTCFS-65-1-JUG-TULIP |
| Device Problems
Difficult to Remove (1528); Obstruction of Flow (2423); Structural Problem (2506); Detachment of Device or Device Component (2907)
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| Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Thrombus (2101); Stenosis (2263); Foreign Body In Patient (2687)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook gunther tulip filter.Occupation: non health care professional.Pma/510(k) k172557.Summary of investigational findings: the reported allegations have been further investigated based on the information provided to date.Filter fracture has been reported and may be either symptomatic or asymptomatic.Fracture of a filter leg may be due to repetitive motion on a filter leg in an unusual, stressed position, such as a filter leg penetrating/perforating the ivc; or a filter leg being caught in a side branch (e.G., a renal vein).Other potential causes of filter fracture may include excessive force or manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Retrieval of a fractured filter or filter fragments (including embolized fragments) using endovascular techniques has been reported.Potential adverse events that may occur include, but are not limited to, the following: filter fracture, filter or filter fragment embolization, trauma to adjacent structures.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.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.Cook medical will continue to monitor for similar events.
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Event Description
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Description of event according to initial reporter: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2014.On (b)(6) 2016, after 2 hours of attempted filter removal the procedure was aborted as the hook broke the hook off the filter, and doctors were unable to the entire filter removed from [pt]'s ivc.Doctors took further precautions by implanting a second suprarenal filter to catch clot, as the broken gunther tulip filter was no longer expanded and/or useful to catch thrombus as it was designed." patient outcome: it is alleged that "[pt] is at risk for future progressive perforations by the remaining portion of the gunther tulip filter which could further injure adjacent organs, blood vessels, and structures, as well as increased risk of migration of the gunther tulip ivc filter pieces.[pt] faces numerous health risks, including the risk of death.[pt] will require ongoing medical care and monitoring for the rest of her life.It is unknown if the remaining filter pieces can be retrieved by any means other than an open surgical procedure.".
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Event Description
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Patient allegedly received an implant on (b)(6) 2014 via the right internal jugular vein due to upcoming hernia repair surgery, followed by an unsuccessful retrieval attempt on (b)(6) 2016 and a successful retrieval on (b)(6) 2016.Patient is alleging fracture, embedment, and post-implant thrombotic event.Patient further alleges "due to the filter¿s failure, i underwent two surgical procedures to have it removed, the first attempted failed, and during this attempt, the filter fractured; the filter was removed after the second attempt through a laser assisted surgery.The filter¿s failure made me live with the anxiety of having a filter that could fail further at any time, and because of the filter¿s failure i had two separate surgical procedures to have it removed," as well as depression and post-traumatic stress disorder (ptsd).Retrieval report (attempted): "chronic thrombus in the infrarenal ivc filter that has been present since 2014.The remainder of the iliacs and femoral veins were nearly 100% clear of thrombus.Slow flow due to chronic thrombus in the filter." "placed suprarenal ivc filter to prevent thrombus as we removed old filter.After 2 hours of attempted filter removal it was aborted.Broke the hook off the filter and was able to get multiple legs off the filter wall but chronic thrombus on the filter prevented it from folding into 20f sheath.At the end of the procedure there was flow around left side of the filter with approximately 50% stenosis due to filter and thrombus of infrarenal ivc.We left suprarenal filter in place as the lower filter is no longer expanded and/or useful to catch thrombus." retrieval report (successful): "successful laser-assisted retrieval of gunther-tulip ivc filter.".
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Manufacturer Narrative
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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: embedment, inferior vena cava (ivc)/filter thrombus, stenosis, anxiety, depression, post traumatic stress disorder (ptsd).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.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.Unknown if the reported anxiety, depression, and post traumatic stress disorder (ptsd) are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 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 become 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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