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Investigation is reopened due to additional information provided.The following allegations have been investigated: pulmonary embolism (pe), fractured strut, vena cava (vc) perforation, occluded vessel, deep vein thrombosis (dvt), inferior vena cava (ivc) stenosis/fibrosis, migration, tilt, discomfort, bilateral lower extremity amputation, limited activity.The reported allegations have been further investigated based on the information provided to date.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 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.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.Filter or filter fragment migration and (or) embolization (e.G., movement to the heart or lungs) has been reported.Filter or filter fragment movement has occurred in both the cranial and caudal direction and may be either symptomatic or asymptomatic.Potential causes may include filter placement in ivcs with diameters smaller or larger than those specified in these instructions for use; improper deployment; deployment into thrombus; dislodgement due to large thrombus burdens; 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: filter migration, trauma to adjacent structures.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 discomfort, bilateral leg amputation, and limited activity are directly related to the filter and unable to identify a corresponding failure mode at this point in time.20 devices in lot.To date, there are 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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Patient allegedly received an implant on (b)(6) 2018 via the right common femoral vein due to post trauma.Patient is alleging device migration, tilt, vena cava perforation, fracture, dvt, caval stenosis, caval thrombosis.Patient notes and further alleges experiencing "discomfort" and "legs were removed shortly after filter was implanted.All activity is now limited".Per the (b)(6) 2018 operative note: "still significant thrombus burden within the ivc and at that juncture passed the penumbra device to the central portion of the previously placed ivc filter with multiple passes i performed suction endovascular embolectomy of the well-formed thrombus".Per the (b)(6) 2018 ct abdomen: "there is an infrarenal ivc filter with several of the medial filter prongs again projecting beyond the luminal margin of the ivc seen on series 2 image 105 and image 97.There is thrombus in the ivc below the level of the filter seen on delayed phase imaging with a moderate to large amount of thrombus in the bilateral common iliac veins, bilateral external iliac veins in bilateral femoral veins.There is thrombus in the right internal iliac vein in distal left internal iliac vein.There is an acute pulmonary embolus in the distal right lower lobe pulmonary artery extending into the right lower lobe segmental branches.No evidence of right heart strain".Per the (b)(6) 2018 operative note-thrombolysis: "we decided at this time to continue with thrombolysis in order to hopefully preserve the channel through the inferior vena cava.An ekos catheter was placed through the left sheath at this time with its tip above the ivc filter in the patent ivc.A 6-french sheath was then placed over the wire into the vein and angiogram showed significant clot burden still in this vein.An ekos catheter was then placed with its tip above the level of the inferior vena cava and the 2 ekos catheters were secured and the patient was then taken intubated back to the icu in stable condition" per the (b)(6)2019 computed tomography (ct) abdomen: "ivc filter as discussed and there is filter tilt as noted.The tip of the filter is in contact with the ivc wall at the 7:00 position.The filter strut at the 2:00 position appears somewhat eccentric however still in contact with the ivc wall with no clear fat plane separating it, therefore by definition no perforation.Ivc stenosis is shown below the filter.This is new since the previous exam.There is filter strut bending toward the left.2 filter struts previously on the left appears to be perforated and the more superior of which is no longer seen and presumably has broken off but is nowhere to be found.The other strut appears to have contracted inward relating to the ivc stenosis/fibrosis".
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