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Reporter occupation: non-healthcare professional.Investigation the reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: fracture, organ/vena cava (v/c) perforation, stenosis, device is unable to be retrieved, migration, nervous, fear, limited physical ability.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.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.Unknown if the reported nervous, fear, and limited physical ability 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.The alleged tulip 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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Patient allegedly received an implant on (b)(6) 2007 via the right common femoral vein due to an inability to be anticoagulated and needed pulmonary embolism (pe) prophylaxis.Patient is alleging fracture, vena cava perforation, migration, and device is unable to be retrieved.Patient further alleges "retained metal pieces which make me nervous", and limited physical activity due to fear of increasing heart rate.(b)(6) 2019: unsuccessful retrieval reported.(b)(6) 2019: successful retrieval report reported.(b)(6) 2019: per ct report: "vasculature: there is no abdominal aortic aneurysm.The portal vein is patent.An ivc filter is noted.Right, anterior, and left legs of the ivc filter appear to extend beyond the vessel.No intraluminal thrombus seen within the inferior vena cava or visualized common iliac, external iliac, and internal iliac vessels." (b)(6) 2019: per unsuccessful retrieval report, "the 5-french kumpe catheter was removed and a 5-french pigtail catheter was placed below the ivc filter.At this point, a metallic fragment was noted overlying the right atrium presumably a prolonged from the ivc filter.This was documented before any intervention on the ivc." "after multiple attempts, the sheath and snare was retracted and unengaged to the ivc filter.After this was done, the ivc filter now had a more narrow appearance." "the ivc along the filter is now significantly narrowed with small amount of contrast within the superior portion of the ivc with numerous collateral circulation through the lumbar veins." "the 11 french sheath with snare was again advanced over the wire just above the ivc filter.The ivc filter hook was snared.The sheath was then used to push the ivc filter inferiorly in the purpose of opening the ivc filter.Multiple attempts were unsuccessful." (b)(6) 2019: per ct report, "there is a metallic structure that is likely to represent part of the ivc filter that appears to be lodged in the right atrial appendage.There is a small low-density pericardial effusion along the right side of the heart.The remainder of the ivc filter is located in suprarenal ivc with its distal end lying just above the level of the renal veins." (b)(6) 2019: per successful retrieval report, "pre-procedure scout radiograph of the abdomen and chest were obtained.Pre-procedure note was made of previously fractured ivc filter strut in the right atrial appendage which was partially imbedded on 1 end and mobile on the other.A previously fractured ivc filter strut is also noted to be imbedded in the anterior portion of the l3 vertebral body." "pre filter removal ivc venogram demonstrates significant stenosis of the ivc at the location of the filter.There is collateral venous return indicating functional stenosis." "successful forceps removal of the ivc filter." "post filter removal ivc venogram demonstrates stenosis in the pararenal ivc at the previous location of the filter." "impression: 1.Successful forceps removal of ivc filter.2.Successful balloon angioplasty of ivc stenosis at the level of the filter.No angiographic appearance or pressure gradient measurement to suggest residual hemodynamically significant narrowing post plasty.3.Previously fractured ivc filter strut remains partially embedded in the right atrial appendage.4.Previously fractured ivc filter strut remains imbedded in the l3 vertebral body".
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