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Occupation: non-healthcare professional (b)(4).Investigation: the following allegations have been investigated: fracture, organ/vena cava perforation, inability to retrieve, tilt, and disfiguring injuries (pain, distress, limited activity).The reported allegations have been 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.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.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 disfiguring injuries (pain, distress, limited activity) are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot# 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.
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Patient allegedly received an implant via the right groin due to post trauma.Patient is alleging device tilt, vena cava and organ perforation and fracture.Patient notes and further alleges experiencing "trouble urinating at times due to part of the ivc filter that was not able to be retrieved was diagnosed with a "neirogenic" bladder because of it.Had to use catheters for 3+ months to urinate", limited physical activity, major depression, anxiety disorder.Per on (b)(6) 2018 computed tomography (ct) angiogram abdomen and pelvis: "ivc filter with the struts extending beyond the contour of the ivc, including the stripe which erodes the anterior aspect of the vertebral body of l3 projecting 1.3 cm into the vertebral body with surrounding lucency with sclerotic margin.Other struts extending anteriorly, one approaching the aorta although not deforming it".Per on (b)(6) 2018 ivc filter removal: "impression: cavagram demonstrating no evidence of thrombus within the ivc filter.Successful retrieval of ivc filter with fractured component confirmed to be in the extravascular space on cone beam ct".
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Additional information: h6 (patient codes).Investigation: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Unknown if the reported dysuria, depression, and anxiety are directly related to the filter and unable to identify a corresponding failure mode at this point in time.Catalog and lot numbers are unknown.The alleged tulip is manufactured and inspected according to controls.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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