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The previous mdr was submitted by wce under manufacturer report reference number 3002808486-2019-01577.Additional information provided determined that this device was manufactured by cinc.With the submission of this initial report, cinc informs that all future submissions regarding this complaint will be handled under manufacturer report number in this initial medwatch report.Occupation: 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: pulmonary embolism, thrombus in filter, unable to be retrieved, stenosis, embedment, tilt, tenting of filter legs, required blood thinners that led to frequent blood draws causing scar tissue in arms; left in 8 years instead of 6 months; difficult clotting, inconveniences and nervous.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.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 tenting of filter legs, required blood thinners that led to frequent blood draws causing scar tissue in arms; left in 8 years instead of 6 months; difficult clotting, inconveniences and nervous is 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 report will be submitted should additional information become available.
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Patient allegedly received an implant on (b)(6) 2011 via right common femoral vein due to post deep vein thrombosis (dvt) and pulmonary embolism (pe).Patient is alleging tilt, device unable to be retrieved, stenosis, embedment and tenting of filter legs.The patient further alleges the device ¿was implanted for approximately 8 years (supposed to be for 6 months) was on blood thinners.Scar tissue in both arms from being drawn so much.Inconvenience of having to give up certain foods ¿ had to be careful not to get cut up.Hospital expenses to have it removed x2 and cost of coumadin and blood tests.Had to wear compression hose.Had to be careful not to get bruised.If i got cut or had blood drawn, it was sometimes hard to get blood to clot or quit bleeding.Asked how long the filter would be in and never told.Constantly having blood work to keep blood thinner checked, sometimes 2x a week.Lots of hospital bills, especially since retired and on medicare.Supplement insurance didn¿t pick up all costs.Prescriptions, trips to pittsburgh, trips to specialist.Had to go to [sic] blood specialist to see if i could have filter removed.They set up appointments in pittsburgh.Had to pay for all appointments.Was always nervous about getting hit or just having the filter.¿ per an ir ivc filter removal operative report (b)(6) 2017, ¿the ivc filter could not be removed.This is likely secondary to the filter becoming embedded within the ivc.¿ per an ir ivc filter removal operative report (b)(6) 2017, ¿uncomplicated ultrasound and fluoroscopic transjugular retrieval of a gunther tulip ivc filter.¿.
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