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Initial reporter occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, 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 a filter via the right common femoral vein as prevention of deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging vena cava and organ perforation, embedment followed by successful percutaneous retrieval utilizing laser and forceps on (b)(6) 2021.Patient notes and further alleges experiencing right upper quadrant pain which resolved less than a month after filter removal as well as dvt and pe post filter implant.Per a computed tomography (ct) abdomen/pelvis: "ivc filter with: - 7 mm small bowel, 7 mm vertebral, and 4 mm mesenteric perforation - tilting with the apex against the wall.- no fracture, stenosis, or migration".Successful filter retrieval: "inferior venacavogram performed.The tip embedded apex of the ivc filter was loop snare, laser sheath could not be advanced over the apex of the filter.Alligator forceps are placed through the sheath, and used to gently teased the apex of the ivc filter off of the wall of the vena cava.Subsequently, the hook could be grasped with a snare"."laser sheath easily advanced over the apex down to the base of the filter.At this point resistance was met.2 applications of laser energy for use, resulting in free removal of the ivc filter intact.Completion cavogram performed.Area of irregularity of the ivc treated with prolonged 20 mm balloon dilatation with completion venogram".Findings: redemonstration of infrarenal cook select ivc filter.Filter is tilted, the apex is tip embedded.At least for deep leg penetration through seen through the wall the ivc is better demonstrated by ct scan.Following removal using advanced technique described above, there is irregularity along the right lateral wall of the mid infrarenal ivc corresponding to the area of previous leg penetration through the wall the ivc.There is also contour abnormality with the appearance suggesting 2 small, less than 5 mm, contained pseudoaneurysms which rapidly washout and there is no free extravasation of contrast.Appearance is slightly improved following prolonged 20 mm balloon angioplasty.There is no caval stenosis.The renal veins are unremarkable"."probable 2 separate less than 5 mm venous pseudoaneurysms off of the right lateral wall the inferior vena cava corresponding to areas of previous deep leg penetration prior to ivc filter removal.Rapid washout without extravasation or associated stenosis.These areas should spontaneously heal without sequela".
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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: pulmonary embolism, organ/vena cava perforation, embedment, deep vein thrombosis (dvt), difficult to remove, tilt, ivc venous pseudoaneurysm, pain.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.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 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 ivc venous pseudoaneurysm, pain is directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 10 devices were manufactured in the reported lot.To date, no other complaints have been reported against the 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 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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