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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation evaluation: cook was informed on (b)(6) 2024 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg.The 70-year-old male patient had an emergency bevar (branched endovascular aortic repair) procedure completed on 17oct2024.The following devices were placed; thoraco-abdominal-side-branch, unibody-24-115, zbis-12-61-41 ¿ right, zsle-13-39-zt ¿ right, zbis-12-61-41 - left, and a zsle-13-39-zt - left.The site completed the one-month follow-up ct performed one day post-procedure.Imaging indicated a type 1c endoleak on the right side zbis and a type iiic endoleak on the left zbis.A reintervention procedure was completed.Percutaneous angioplasty of the left iliac was completed.The patient was discharged home on (b)(6)2024.The patient was not prescribed supplemental oxygen at discharge.The patient was prescribed acetylsalicylic acid (asa), clopidogrel, and a statin at discharge.Imaging determined on the left side there appeared to be a type iiia endoleak between the left iliac leg graft (zsle-13-39-zt) and the common iliac limb of the left zbis.This investigation will capture the endoleak involving the zsle-13-39-zt.Reviews of documentation including the complaint history, device history record (dhr), drawings, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, imaging was provided and reviewed by an expert image reviewer.The image review confirmed a type 3a endoleak between the left iliac leg and the distal end of the bridging stent, possibly due to insufficient ballooning (it was fixed with a balloon angioplasty).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 dhrs for the reported complaint device lot and the related subassembly lots revealed no related non-conformances.A complaint history search identified no other lot related complaints.Evidence provided by the complaint facility, device failure analysis, device history record, complaint history, and manufacturing documents suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev4 ¿zenith spiral-z aaa iliac leg with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: 4 warnings and precautions: 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 aneurysm 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 ¿ multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to type ii endoleaks.Patients with uncorrectable coagulopathy may also have an increased risk of type ii endoleak or bleeding complications.4.3 pre-procedure measurement techniques and imaging 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.4.4 device selection: ¿ strict adherence to the zenith spiral-z aaa iliac leg ifu sizing guide is strongly recommended when selecting the appropriate device size.Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding or compression.4.5 implant procedure ¿ inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ aneurysm enlargement.¿ aneurysm rupture and death.¿ endoleak.¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perifgraft flow; and corrosion.8 patient counseling information 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 final angiogram 1.Postion angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kins and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.12.1 general.¿ 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 additional follow-up.¿ physicians should evaluate patients on an individual bases and prescribe follow-up relative to the needs and circumstances of each individual patient.The minimum requirement for patient follow-up (described in the instructions for use for the zenith aaa device that was used) should be maintained even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.Based on the information provided and the results of the investigation, cook was unable to determine a definitive cause.However, it is possible the complaint was procedure related due to insufficient ballooning.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, 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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Cook was notified that a type 3a endoleak was identified in post procedural imaging on a zenith flex with spiral-z technology aaa endovascular graft iliac leg that was placed on (b)(6) 2024.The patient completed pre-procedural computed tomography (ct) with contrast imaging on (b)(6) 2024, 15 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 planned to be incorporated into the repair.All arteries mentioned were patent and no stenosis greater than 50% was identified.The superior mesenteric artery (sma) was incorporated in the repair.The artery was patent.The artery was not stenosed more than 50%.The right renal artery was incorporated in the repair.The artery was patent.The artery was not stenosed more than 50%.The left renal artery was incorporated in the repair.The artery was patent.The artery was not stenosed more than 50%.The right common iliac artery was patent.The left common iliac artery was patent.The right and left internal iliac arteries were patent.The aortic valve was native.There was no aortic arch bovine configuration.The maximum diameter of the diseased aorta on centerline was 61 mm.The intended proximal seal 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 branched endovascular aortic repair (bevar) procedure on (b)(6) 2024 under general anesthesia.The patient had presented with a symptomatic bronchial artery aneurysm (baa) that necessitated the need for an urgent bevar procedure.The patient was not given antiplatelet therapy at the time of the procedure.Percutaneous access was achieved in the right and left femoral arteries.An endovascular iliac conduit was not performed at the time of the procedure.During the procedure, the patient had the following stents placed: celiac artery: a competitor's stent measuring 8 mm in diameter and 38 mm in length was placed.The artery was revascularized with the fenestrated-branched device.The side branch catheterization and placement of the bridging stent was successful.The stent patency was maintained with normal end artery perfusion.The covered stent was not relined or extended with a bare metal stent.Superior mesenteric artery (sma): a competitor's stent measuring 10 mm in diameter and 60 mm length was placed as well as another competitor¿s stent measuring 8 mm in diameter and 32 mm in length.The artery was revascularized with the fenestrated-branched device.The side branch catheterization and placement of the bridging stents was successful.The stents patency was maintained with normal end artery perfusion.The covered stents were not relined or extended with a bare metal stent right renal artery: a competitor's stent measuring 9 mm in diameter and 50 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 8 mm in diameter and 75 mm in length was placed as well as another competitor¿s stent measuring 8 mm in diameter and 17 mm in length.The artery was revascularized with the fenestrated-branched device.The covered stents were not relined or extended with a bare metal stent.The side branch catheterization and placement of the bridging stents was successful.The stents patency was maintained with normal end artery perfusion.Cook custom made device (cmd): rpn: thoraco-abdominal-side-branch was placed.No technical difficulties in the delivery and deployment of the thoracic cmd device were experienced.The delivery and deployment of the thoracic cmd device was considered successful.A cook zenith universal distal body endovascular graft, rpn: unibody-24-115 was placed.There were no technical difficulties in the delivery and deployment of the device.The device delivery and deployment was considered successful.A cook zenith branch endovascular graft iliac bifurcation, rpn: zbis-12-61-41 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 zenith flex with spiral-z technology aaa endovascular graft iliac leg, rpn: zsle-13-39-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 zenith branch endovascular graft iliac bifurcation, rpn: zbis-12-61-41 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.During the procedure stenosis greater than 50% was identified.However, the location was not specified.No treatment was performed to address the stenosis.Procedural imaging in the form of an angiogram was completed on (b)(6) 2024.All stent grafts and intended side branch stents were patent at the conclusion of the procedure.There was no evidence of stent graft integrity issues.All target side branch stents were intact.A type 1c endoleak on the side branch of the iliac branch device was identified.The estimated blood loss during the procedure was 0 ml.During the procedure no blood products were given to the patient.Cardiac output reduction was not used.Carbon dioxide flushing was not used.The proximal seal zone was the native aorta.No neuromonitoring was used during the procedure side branch catheterization and placement of all bridging stents was successful.No additional procedures were performed during procedure.The patient did not have any significant medical problems or complications during the procedure.Total contrast volume used during the procedure: 151 ml contrast dose: 2 ml/kg fluoroscopy time: 60 minutes total gray used: 1478 (mgy) total dose area product: 58 cgy*cm2 fusion was used during the procedure.Procedural time (24-hour clock): time arrives in room: 08:10 time of first incision or arterial puncture: 08:48 time of last access closure: 12:45 time leaves room: 13:15 duration of procedure (from first incision to last access closure): 237 minutes the patient was extubated in the operating room.The patient transferred to the intensive care unit where he remained for three nights.A spinal drain was not placed.The patient did not require reintubation or a tracheostomy.A follow up computed tomography scan with contrast was completed on (b)(6) 2024, one day post procedure.No stenosis greater than 50% was identified in the celiac, right renal or left renal artery.The superior mesenteric artery had stenosis greater than 50%.The stenosis was within the stent.All stent grafts were patent.A persistent type 1c endoleak on the right iliac branch device was identified.A persistent type iiic endoleak from left iliac branch component was identified.The maximum diameter of the diseased aorta was 60 mm.There was no stent graft integrity issues.All intended side branch stents were intact.A stenosis was identified on (b)(6) 2024 in the sma.On (b)(6) 2024, relining of the ¿lna¿ was completed.On (b)(6) 2024 a type iv endoleak was identified.Relining and pta of the left side prosthesis was completed.On (b)(6) 2024, two days post procedure, a reintervention procedure was completed.Imaging indicated a type 1c endoleak on the side branch, a type iiic endoleak from the branch component, occlusion, and in stent stenosis.The in-stent stenosis occurred in the superior mesenteric artery.Pre-stenosis occurred in ¿front of rna¿ percutaneous angioplasty of the left iliac was completed.An uncovered stent was placed in the left renal artery.A competitor¿s graft 11 mm x 79 mm was placed procedure.The intervention was not considered successful.A type iv endoleak remained when the procedure was completed.The patient was discharged home on (b)(6) 2024.The patient was not prescribed supplemental oxygen at discharge.The patient was prescribed acetylsalicylic acid (asa), clopidogrel, and a statin at discharge.The patient did not have any significant medical problems or complications after the procedure and before discharge.On (b)(6) 2024, six days post procedure, a follow up clinical assessment was completed.The patient was prescribed acetylsalicylic acid (asa), and anticoagulant (not specified), and a statin.Follow up imaging in the form of a computed tomography (ct) scan was completed during the follow up clinical assessment.On (b)(6) 2024, 13 days post procedure occlusion was identified (graft or vessel unspecified).A secondary intervention was attempted but was stopped due to the report of patient pain.The patient was hospitalized.The patient was discharged on (b)(6) 2024.The subject of this report is the type 3a endoleak on the left zsle-13-39-zt discovered one day post implant on ct.A secondary procedure was completed on (b)(6) 2024 where percutaneous angioplasty of the left iliac was completed.
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