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Cook was notified that seventeen days after implant, a thrombosis in the right zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-56-zt) placed most proximally was identified.The patient underwent a pre-procedural computed tomography (ct) scan with contrast imaging on (b)(6) 2022.This was 611 days prior to the procedure.The innominate artery, right common carotid artery, right subclavian artery, left common carotid artery, left subclavian artery, and celiac artery were incorporated into the repair.All arteries mentioned were patent and no stenosis greater than 50% was identified.The right common iliac artery and right internal iliac artery were patent.The left common iliac artery and left internal iliac artery were patent.The aortic valve was native.The maximum diameter of the diseased aorta on centerline was 61 mm.The intended proximal seal zone was zone 5: mid descending aorta to celiac the left and right intended distal landing zone was zone 10: common iliac arteries.The patient underwent a fenestrated endovascular aortic repair (fevar) procedure on (b)(6) 2024 under general anesthesia the patient was prescribed acetylsalicylic acid (asa) at the time of the procedure.Percutaneous access was achieved in the left and right femoral arteries.An iliac conduit was not performed the time of the procedure.The proximal seal zone was the native aorta.Side branch catheterization and placement of all bridging stents was successful.No additional procedures were performed during the custom-made device (cmd)/fevar procedure.During the procedure, the patient had the following stents placed: right renal artery: a competitor's stents measuring 6 mm in diameter and 22 mm in length was placed.The artery was revascularized with the fenestrated-branched device.The covered stent was not relined or extended with a bare metal stent.The side branch catheterization and placement of the bridging stent was successful.The stent patency maintained with normal end artery perfusion.Left renal artery: a competitor's stents measuring 6 mm in diameter and 16 mm in length was placed.The artery was revascularized with the fenestrated-branched device.The covered stent was not relined or extended with a bare metal stent.The side branch catheterization and placement of the bridging stent was successful.The stent patency maintained with normal end artery perfusion.Superior mesenteric artery (sma): a competitor's stent measuring 8 mm in diameter and 29 mm length was placed.The artery was revascularized with the fenestrated-branched device.The covered stent was not relined or extended with a bare metal stent.The side branch catheterization and placement of the bridging stent was successful.The stent patency was maintained with normal end artery perfusion.Celiac artery: a competitor's stent measuring 8 mm in diameter and 29 mm in length was placed.The artery was able to be revascularized with the fenestrated-branched device.The covered stent was not relined or extended with a bare metal stent.The side branch catheterization and placement of the bridging stent was successful.The stent patency was maintained with normal end artery perfusion.A cook zenith fenestrated graft (rpn: fen-thoraco-abdominal-graft) that was planned for this patient was placed.No technical difficulties in the delivery and deployment of the custom -made device (cmd) were experienced.The delivery and deployment of the cmd device was considered successful.A cook distal body (rpn: aaa-bifurcated-graft) was placed.There were no technical difficulties in the delivery and deployment of the device.The delivery and deployment of the device was considered successful.Iliac artery component: a cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt) was placed on the patient's right.There were no technical difficulties in the delivery and deployment of the device.The delivery and deployment of the device was considered successful.Iliac artery component: a cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt) was placed on the patient's left.There were no technical difficulties in the delivery and deployment of the device.The delivery and deployment of the device was considered successful.A cook coda balloon catheter (rpn: coda-2-9.0-35-120-32) was used in the procedure.The device successfully targeted the vasculature and performed as intended.There were no device deficiencies.Four cook safe-t-j rosen catheter exchange wire guides (rpn: thscf-35-260-1.5-rosen) were used in the procedure.The devices successfully targeted the vasculature and performed as intended.There were no device deficiencies.Procedural imaging was completed on (b)(6) 2024.All stent grafts and intended side branch stents were patent at the conclusion of the procedure.All target vessels were patent.This was confirmed by angiogram.A type ii endoleak was present at the conclusion of the procedure.This was confirmed by angiogram.There was no evidence of stent graft integrity issues.All target side branch stents were intact.The patient was extubated in the operating room.A spinal drain was not placed during the procedure.The patient did not require reintubation.The patient did not require a tracheostomy.Procedural time (24-hour clock): time arrives in room: 08:15, time of first incision or arterial puncture: 09:18, time of last access closure: 13:52, time leaves room: 14:00, duration of procedure (from first incision to last access closure): 274 minutes.Total contrast volume used during the procedure: 230 ml, contrast dose: 2.9 ml/kg, fluoroscopy time: 91 minutes, total gray used: 5 mgy, total dose area product: 717 cgy*cm2, fusion was used during the procedure.The estimated blood loss during the procedure was 300 ml.During the procedure no red blood cells/fresh frozen plasma/cryoprecipitate/platelets/cell saver were not given to the patient during the procedure.Cardiac output reduction, carbon dioxide flushing, and neuromonitoring were not used during the procedure.One day post procedure the patient experienced urinary retention/residual urine after attempting to empty the bladder.An indwelling urinary catheter was placed in the patient.This event (urinary retention) was not considered related to the study device.However, it was considered to be possibly related to the procedure.The elderly patient had undergone a procedure under general anesthesia and had reduced function post operatively.The patient recovered without sequelae.The patient did not have any significant medical problems or complications after the procedure and before discharge.At discharge, the patient was prescribed acetylsalicylic acid (asa), and a statin.However, he was not prescribed an anticoagulant or supplemental oxygen.The patient was discharged home on (b)(6) 2024.On (b)(6) 2024, 17 days post procedure, the patient had arterial thrombosis of the most proximal right zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt).This was considered possibly related to a device used in the procedure.The facility reported ¿difficult to discern, but thrombosis may possible be related to insufficient outflow from this device.¿ additionally, it was reported that the event may be possibly related to the treated disease as the elderly patient had vessels that were aneurysmal and atherosclerotic.The thrombosis event resulted in in-patient hospitalization.The patient was hospitalized on (b)(6) 2024.A secondary procedure where stenting and a thrombectomy was performed.The patient was discharged on (b)(6) 2024.On (b)(6) 2024, 30 days post procedure the patient was diagnosed with a urinary tract infection (uti).The patient was prescribed antibiotics.This event was not considered to be related to the study procedure or related to any of the devices used in the procedure.The subject of this report is the thrombosis of the right zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-56-zt) that resulted in patient hospitalization and a secondary procedure where stenting and a thrombectomy was performed.
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Investigation-evaluation: cook was notified that seventeen days after implant, a thrombosis in the right zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-56-zt) placed most proximally was identified.The patient underwent a fenestrated endovascular aortic repair (fevar) procedure on (b)(6) 2024 under general anesthesia.During the procedure, the patient had the following non-cook stents placed: a competitor's stents measuring 6 mm in diameter and 22 mm in length implanted in the right renal artery.A competitor's stents measuring 6 mm in diameter and 16 mm in length was implanted in the left renal artery.A competitor's stent measuring 8 mm in diameter and 29 mm length was implanted in the superior mesenteric artery (sma).A competitor's stent measuring 8 mm in diameter and 29 mm in length was implanted in the celiac artery.The following cook devices were implanted: cook zenith fenestrated graft (rpn: fen-thoraco-abdominal-graft) cook distal body (rpn: aaa-bifurcated-graft) cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt) implanted on the patient's right.Cook zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt) implanted on the patient's left.Procedural imaging was completed on (b)(6) 2024.All stent grafts and intended side branch stents were patent at the conclusion of the procedure.All target vessels were patent.A type ii endoleak was present at the conclusion of the procedure.One day post procedure, the patient experienced urinary retention/residual urine after attempting to empty the bladder.An indwelling urinary catheter was placed in the patient.The patient recovered without sequelae.The patient did not have any significant medical problems or complications after the fevar procedure and before discharge.On (b)(6) 2024, 17 days post procedure, the patient had arterial thrombosis of the most proximal right zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt) from the bifurcation to the distal landing zone.The customer reported that this was most likely due to compression from the contralateral prothesis.The thrombosis event resulted in in-patient hospitalization on (b)(6) 2024.A secondary procedure was performed where a competitor¿s balloon expandable extent was placed and a thrombectomy was performed.The patient was then discharged on (b)(6) 2024.It was reported that the there was no pre-existing thrombus of concern that would explain the thrombotic event.However, it was reported that the elderly patient had vessels that were aneurysmal and atherosclerotic.On (b)(6) 2024, 30 days post procedure the patient was diagnosed with a urinary tract infection (uti).The patient was prescribed antibiotics.The focus of this report is the thrombus that developed in the zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt) 17 days post procedure.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.An expert reviewed the imaging for the investigation.The image reviewer indicated that the problem may have been the patient¿s anatomy and arterial disease.The tortuosity and angulation of the right common iliac artery (cia) may have resulted in a degree of kinking of the right zsle, which in turn may have led to the thrombosis.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot and related subassembly lots revealed no recorded non-conformances relevant to the failure mode.A complaint history search did not indicate any related complaints for this lot number.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: 4.1 general ¿ additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysms, size and/or persistent endoleak or migration may lead to aneurysm rupture ¿ 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: ¿ zenith spiral-z iliac artery distal fixation sire greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair.¿ 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 leg graft.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.¿ the zenith spiral-z aaa iliac leg with the z-trak introduction system is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and postoperative follow-up imaging.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.¿ inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia lengths: ¿ all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.4.5 implant procedure: ¿ inaccurate placement and/or incomplete sealing of the zenith spiral-z endovascular aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries ¿ excessive overlap 10 mm above the main body bifurcation may increase the risk of limb thrombosis.¿ 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.5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: ¿ aortic damage, including perforation, dissection, bleeding, rupture and death ¿ arterial or venous thrombosis and/or pseudoaneurysm ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component/ suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; peri graft flow; and corrosion ¿ graft or native vessel occlusion ¿ renal complications and subsequent attendant problems (e.G., dehiscence, infection) ¿ vessel damage 7.1 individualization of treatment: the risks and benefits should be carefully considered for each patient before use of the zenith spiral-z aaa iliac leg.Additional considerations for patient selection include, but are not limited to: ¿ patient¿s age and life expectancy ¿ co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity) ¿ patient¿s suitability for open surgical repair ¿ patient¿s anatomical suitability for endovascular repair ¿ the risk of aneurysm rupture compared to the risk of treatment with zenith spiral-z aaa iliac leg ¿ patient¿s ability to tolerate general, regional or local anesthesia ¿ iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 14 french to 16 french vascular introducer sheath ¿ zenith spiral-z iliac artery distal fixation site greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall) ¿ freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft.The final treatment decision is at the discretion of the physician and patient.8 patient counseling information in addition to the risks and benefits of an endovascular repair, the physician should assess the patient¿s commitment and compliance to postoperative follow-up as necessary to ensure continuing safe and effective results.Listed below are additional topics to discuss with the patient as to expectations after an endovascular repair: ¿ all patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.At a minimum, annual imaging and adherence to routine postoperative follow-up requirements is required and should be considered a life-long commitment to the patient¿s health and well-being.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death.11 directions for use: anatomical requirements ¿ iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories.Arterial conduit techniques may be required.Based on the information provided, no product returned, and the results of the investigation, a definitive root cause for this event could not be established.The image reviewer indicated that the patient anatomy (tortuosity and angulation of the right common iliac) and arterial disease may have contributed to the event.The image review noted that the pre-operative ct scan shows some tortuosity and wall disease of the right common iliac artery.Additionally, intraoperative imaging (angiography) shows a possible kink in the implanted cook zenith flex with spiral-z technology aaa endovascular graft iliac leg placed on the right.The image reviewer indicated the kink in the device may have led to thrombosis.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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 or that a death or serious injury occurred; nor is it admission 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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