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The previous medwatch report was submitted by william cook europe under manufacturer report reference# 3002808486-2023-00297.Additional information provided determined that this device was manufactured by cook inc.With the submission of this initial medwatch report, cook inc.Informs that all future submissions regarding this complaint will be handled under the manufacturer report reference # referenced in g8 of this initial medwatch report.Blank fields on this form indicate the information is unknown or unavailable.Section e3: non-healthcare professional 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, organ (org)/vena cava (vc) perforation, embedment, stenosis complex removal, tilt, pain, weakness, distress, limited physical activity.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).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 pain, weakness, distress, and limited physical activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.A total of 20 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 current 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 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 a gunther-tulip inferior vena cava (ivc) filter on (b)(6) 2011 via the right internal jugular vein due to a history of pulmonary embolism (pe) and inability to take anticoagulants.Patient is alleging device tilt, vena cava and organ perforation (with tines abutting the abdominal aorta and the psoas muscle), device fracture, unable to be retrieved, and embedment.It is alleged the patient underwent two unsuccessful percutaneous filter retrieval attempts ((b)(6) 2022) and a final successful percutaneous retrieval ((b)(6) 2022) with two fractured tines remaining in patient.Patient notes and further alleges experiencing pain and distress restricting the ability to engage in activities of daily living as well as use of approximately "20% of my hands my back", patient cannot get up or down; "they broke the hook of filter off in my kidney and can never get it out"."i cant lift, hold anything w/hands weak".Per a ct abdomen/pelvis: "an ivc filter is noted within the inferior vena cava.The ivc filter extends struts extent beyond the ivc wall.One prong/strut abuts the aorta.Another abuts the psoas muscle.There is extension of the struts beyond the ivc wall of more than 3 mm suggesting caval perforation.There is an irregular shaped fluid collection with mild rim enhancement immediately posterior to the ivc at the level of the ivc filter and partially within the psoas with some extension into the aortocaval space"."impression: ¿ findings may relate to infectious process and developing abscess, correlate clinically".Per a venogram: unsuccessful filter retrieval: "the patient was found to have a ivc filter in place with multiple struts protruding outside the inferior vena cava possibly into the aorta and the duodenum.The fluid collection was aspirated by interventional radiology and is sterile.The patient has no evidence of dvt at this time and states no previous history of dvt with the filter being placed after a car accident"."this demonstrated that a filing [sic] defect in the middle of the middle of the inferior vena cava just below the hook of the filter.The filter also appeared to be tilted to the right with the hook likely into the ostium of the right renal vein.Because of this i felt there was significantly high risk for complication including avulsion of the right renal vein, and therefore aborted the procedure at that time".Per the successful filter retrieval report: "peripheral stenosis: venogram patent infra-renal ivc by angiography.A conical ivc filter, positioned below the renal veins, patent, with severe right lateral tilting, the filter hook was embedded into the right renal vein.All struts are outside of the ivc confine.There was an stricture of the ivc at the sites of the primary struts"."conclusions: conical ivc filter with fractured secondary struts and lateral tilting into the right renal vein.Successful retrieval of the above ivc filter.There were two small secondary strut fragments that were well embedded into the posterior wall of the ivc not retrievable despite multiple attempts with forceps.Further attempts to retrieve the fractured secondary strut fragments can result in perforation of the ivc.Therefore, the two small fractured secondary strut fragments were left in place.Complex procedure requiring multiple catheters, wires, and instruments to successfully retrieve this ivc filter".
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