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Investigation ¿ evaluation: the complainant, (b)(6) hospital located in australia, informed cook on 20jan2020 of an incident that was observed on (b)(6) 2020 involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg with rpn zsle-20-74-zt from lot 7131333.The patient had a history of hypertension, stroke, left carotid endarterectomy, colonic polyps, bronchopneumonia (treated), and a microaneurysm in the right eye.In (b)(6) 2017, the patient had an endovascular aortic repair for an abdominal aneurysm, and four cook devices were implanted.The patient was on aspirin and clopidogrel either prior to or following the graft placement.On (b)(6) 2020, the physician observed thrombus formation in the left iliac leg graft from a computed tomography angiography (cta), likely the 2-year postop follow-up.This thrombus formation was confirmed by the cook rep.Upon review, it appeared that the thrombus extended into the main body graft as well.Upon further review, the physician believed that the thrombus was present in the right iliac leg grafts as well.The physician is planning ¿a graft to jail the thrombus¿, but at this time no additional interventions have been performed.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control and specifications, as well as a review of imaging provided by the customer, were conducted during the investigation.The imaging provided by the customer was sent to an expert for image review.Thrombus formation was observed in the main body graft and bilateral iliac leg grafts.The image reviewer observed that the aortic neck appeared to have reverse funnel anatomy and intermittent diameter fluctuation.Additionally, both iliac leg grafts were placed more than the recommended distance above the main body bifurcation, as listed in the ifu.The left iliac leg graft was observed to have an overlap of 57 mm in the ipsilateral limb, which would place the flared segment of the graft to begin right at or within the main body graft limb junction, which could contribute to thrombus formation.Based on the evidence provided and observed, cook has concluded that the device was manufactured to current specifications.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the affected product is safe and effective for its intended use.A review of the device history record for this complaint lot found no related nonconformances or additional complaints.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: 4 warnings and precautions.4.1 general: patients experiencing reduced blood flow through the graft limb and/or leaks may be required to undergo secondary interventions or surgical procedures.4.2 patient selection, treatment and follow-up: adequate iliac or femoral access is required to introduce the device into the vasculature.Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity, occlusive disease and/or calcification) should be compatible with vascular access techniques and delivery systems of a 14 french to 16 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.Pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.Dilatation of these regions with a noncompliant balloon and/or stent placement may be necessary to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Additionally, the completion angiogram (with stiff wire guides removed) should be reviewed carefully to determine if further treatment in these regions is necessary (e.G., adjunctive ballooning or stenting).Failure to remove the stiff wire guide prior to the angiogram could mask any limb kinking or narrowing that might occur when the wire guide is removed.Follow-up imaging should be carefully reviewed for narrowing within the graft leg.Patients with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.4.5 implant procedure: systemic anticoagulation should be used during the implant procedure based on hospital- and physician-preferred protocol.If heparin is contraindicated, an alternative anticoagulant should be considered.Use caution during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization, or may rupture the aneurysm.Excessive overlap 10 mm above the main body bifurcation may increase the risk of limb thrombosis.5 adverse events.5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: arterial or venous thrombosis and/or pseudoaneurysm.Claudication (e.G., buttock, lower limb).Embolization (micro and macro) with transient or permanent ischemia or infarction.Endoprosthesis: occlusion.Graft or native vessel occlusion.Renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure).11 directions for use.11.1 zenith spiral-z aaa iliac leg system: 11.1.4 contralateral iliac leg placement and deployment: 3.Introduce the contralateral iliac leg delivery system into the artery.Advance slowly until at least one stent of the iliac leg graft overlaps within the main body and not past the radiopaque marker band positioned 30 mm from the proximal end of the iliac leg graft inside the contralateral limb of the main body.4.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency, a minimum overlap of one stent, and a maximum overlap of 30 mm within the main body endovascular graft.11.1.5 ipsilateral iliac leg placement and deployment: 2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one stent inside the ipsilateral limb of the main body.3.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency.Based on the information provided, no inspection of the product, and the results of the investigation, a definitive cause can be traced to user failure to follow instructions and patient pre-existing conditions.Additionally, thrombus is a known inherent risk of these devices.Appropriate measures have been taken to address this failure mode.A request to initiate capa was submitted however no decision was made to initiate a capa.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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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