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Patient allegedly received an implant on (b)(6) 2010 via the left femoral vein due to deep vein thrombosis.Patient is alleging device tilt, vena cava and organ perforation.Two unsuccessful filter retrieval attempts have been reported on (b)(6) 2010 and (b)(6) 2020.Patient notes and further alleges experiencing "back pain, chest pain, stress".Per the (b)(6) 2010 inferior vena cava filter placement and unsuccessful removal attempt due to malpositioning: "there are no venous anomalies.There is no thrombus in the ivc.A celect ivc filter was placed.Repeat venogram demonstrated placement encroaching on the left renal vein.Therefore a decision was made to attempt to remove the filter"."impression: 1.Placement of ivc filter, with unsuccessful removal for reposition with filter now angulated in the suprarenal ivc.2.Discussed with vascular surgery.Will evaluate tomorrow am".Per the (b)(6) 2010 computed tomography (ct) abdomen: "findings: two snare type guidewires are seen extending from the superior aspect of the scan inferiorly through the right atrium, and terminating in the intrahepatic and infrahepatic ivc.An ivc filter is noted within the intrahepatic ivc, just inferior to the confluence of the hepatic veins with the intrahepatic ivc.The ivc filter is markedly deformed with multiple areas of acute angulation within the filter tines.The inferior most guidewire appears to be tenting the inferior aspect of the infrarenal ivc, with the tip possibly lying outside of the ivc lumen (series 7, image 23).Additionally at least one of the ivc filter tines appears to be projecting beyond the lumen of the intrahepatic ivc.A small amount of high attenuation fluid is seen posterior to the infrahepatic suprarenal ivc, consistent with a small paracaval hematoma.The ivc is slitlike its intrahepatic portion, however no ivc thrombus is identified".Per a (b)(6) 2018 computed tomography (ct) abdomen: "there is a vena cava filter in the intrahepatic vena cava.This is well above the renal veins.Several of the struts are outside the caval wall two of which approached 10 mm beyond the wall.These to struts may be imbedded in the diaphragm.A third strut extends to the renal capsule on the right several of the struts are likely embedded in the hepatic parenchyma.I do not identify a hematoma".
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Additional information: a2, a4, b1, b5, b6, b7, h6 (patient and device codes).H6 (device code): appropriate term/code not available (3191) for alleged device perforation.H6 (device code): appropriate term/code not available (3191) for alleged device tilt.Investigation: investigation is reopened due to additional information provided.The following allegations have been investigated: vena cava (vc)/organ perforation, embedded, unable to retrieve, tilt, malposition, hematoma, back/chest pain, stress.The reported allegations have been further investigated based on the information provided to date.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 malposition, hematoma, back/chest pain, and stress 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, however, the alleged celect is manufactured and inspected according to controls.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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