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The following fields were updated per additional information received: a2, a4, b1, b5, b6, b7, h6.H6 device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation and tilt.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: fracture, vena cava (vc)/organ/aorta perforation, deep vein thrombosis (dvt), unable to retrieve, migration, tilt, stomach pain, fear, depression, anxiety, physical limitations.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.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.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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 stomach pain, fear, depression, anxiety, and physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog number and lot number are unknown; however, 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.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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Patient allegedly received an implant on (b)(6) 2012 via the right common femoral vein due to "repeated blood clots in my legs and one time 2 clots in my lung." patient is alleging migration, tilt, vena cava perforation, fracture, device is unable to be retrieved, and organ perforation.The patient further alleges "my stomach hurts.I am afraid to exercise, lift anything.Cant bend down.I am afraid that one day i might die.I have a lot of depression.I need help with a lot of stuff i cant do" and "physical therapy for my back.I ended it when i found out about my ivc filter and back," as well as post-implant dvt.The patient also states "anxiety and depression since i was around 22 years old.My physicians regarding my ivc that i am afraid to die.No doctor i have seen can do anything about my filter.Every doctor says i would die if they tried.My psychiatrist put me on another antidepressant." report from ct: "impression: fractured ivc filter with a strut in the right retroperitoneal mesenteric fat.Perforation of ivc filter struts into aorta." report from ct: "ivc filter present with anchor penetration into the adjacent retroperitoneum.One such anchor appears to penetrate the aortic media although no evidence of retroperitoneal hemorrhage." report from xray: "ivc filter in place with leads one fracture leg located slightly superior to the normal position of the filter.On ct the fracture line has migrated to the peritoneal fat lateral to the ivc.Prior ct had demonstrated findings concerning for penetration of the adjacent aorta, however, this cannot be characterized with plain film." report from ct: "there is a redemonstrated fractured infrarenal ivc filter with increased penetration into the surrounding retroperitoneum.One and likely 2 such anchors appear to penetrate the adjacent aortic media wall, essentially unchanged from the previous examination.An additional anchor protrudes anteriorly and may be penetrating the posterior wall of the duodenum, series 5 image 121, this is more conspicuous than the prior exam.".
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