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Cook was notified that during procedural imaging on (b)(6) 2024, a type 3a endoleak on a zenith flex with spiral-z technology aaa endovascular graft iliac leg was identified.Pre-procedural computed tomography (ct) with contrast imaging was completed on 31oct2023.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 diameter of the aorta at the celiac artery (measured outer wall to outer wall) was 39 mm.The diameter of the celiac artery at the intended fixation site (inner wall to inner wall) was 8 mm.The superior mesenteric artery (sma) was incorporated in the repair.The artery was patent.The artery was not stenosed more than 50%.The diameter of the aorta at the sma (outer wall to outer wall) was 59 mm.The distance from the celiac artery to the middle of the sma was 30 mm.The diameter of the sma at the intended fixation site (inner wall to inner wall) was 8 mm.The right renal artery was incorporated in the repair.The artery was patent.The artery was not stenosed more than 50%.The diameter of the aorta at the right renal artery (measured outer wall to outer wall) was 22 mm.The distance from the celiac artery to the middle of the right renal artery measured 54 mm.The diameter of the right renal artery at the intended fixation site (inner wall to inner wall) was 4 mm.The left renal artery was incorporated in the repair.The artery was patent.The artery was not stenosed more than 50%.The diameter of the aorta at the left renal artery (measured outer wall to outer wall) was 22 mm.The distance from the celiac artery to the middle of the left renal artery measured 57 mm.The diameter of the right renal artery at the intended fixation site (inner wall to inner wall) was 4 mm.The right common iliac artery was patent.The maximum diameter at the intended fixation site was 9 mm.The maximum diameter was 9 mm.The length from the celiac artery to the iliac bifurcation was 225 mm.The left common iliac artery was patent.The maximum diameter at the intended fixation site was 9 mm.The maximum diameter was 26 mm.The length from the celiac artery to the iliac bifurcation was 226 mm.The right and left internal iliac arteries were patent.The aortic valve was native.There was no aortic arch bovine configuration.The method of length measurement was centerline.The intended proximal seal zone was described as parallel.It was free of occlusive disease, calcification, and thrombus.The largest diameter of the proximal neck was 36 mm.The length of the proximal neck was 74 mm.The primary indication for the procedure was a thoracic abdominal aortic aneurysm (taaa).Extent iv (abdominal aneurysm extending up to the celiac axis).The patient underwent a procedure on 15apr2024 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 endovascular iliac conduit was performed at the time of the procedure.Total contrast volume used during the procedure: 70 ml contrast dose: 300 ml/kg fluoroscopy time: 72 minutes total gray used: 6648 mgy total dose area product: 606 total does area product units: cgy*cm2 fusion was used during the procedure.The estimated blood loss during the procedure was 400 ml.During the procedure no red blood cells/fresh frozen plasma/cryoprecipitate/platelets/cellsaver were given.Cardiac output reduction was not used.Carbon dioxide flushing was not used.No neuromonitoring was used during the procedure.Procedural time (24-hour clock): time arrives in room: 08:15 time of first incision or arterial puncture: 09:15 time of last access closure: 13:56 time leaves room: 14:22 duration of procedure (from first incision to last access closure): 281 minutes during the procedure, the patient had the following stents placed: celiac artery: a competitor's stent measuring 8 mm in diameter and 50 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 second stent was placed in the celiac artery.A competitor's stent measuring 8 mm in diameter and 39 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.Superior mesenteric artery (sma): a competitor's stent measuring 8 mm in diameter and 75 mm length was placed as well as another competitor's stent measuring 8 mm in diameter and 39 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.Right renal artery: a competitor's stents measuring 5 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 29 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.A low profile 20 french thoracic proximal extension custom-made device (cmd) from another manufacturer (38 mm proximal diameter, 22 mm distal diameter, and 227 mm in length) was placed.The device was planned for this patient.The cmd did not have a bare stent.The reference point for measurements was the middle of the celiac artery.The distance from the reference point to the aortic bifurcation was 122 mm.No technical difficulties in the delivery and deployment of the thoracic proximal extension cmd device were experienced.The delivery and deployment of the thoracic proximal extension cmd device was considered successful.A distal body (rpn: aaa-dist-body-inverted-leg) from another manufacturer was placed.The proximal size of the aortic device was 24 mm.No technical difficulties in the delivery and deployment of the main cmd device were experienced.The delivery and deployment of the main cmd device was considered successful.Iliac artery component: a zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-11-56-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 zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-11-56-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-2-10.0-35-140-46) was used in the proximal and distal sealing zone.The device successfully targeted the vasculature and performed as intended.There were no device deficiencies.A cook safe-t-j rosen catheter exchange wire guide, rpn: thscf-35-260-1.5-rosen was used in the ipsilateral access site to access the renal artery.The device successfully targeted the vasculature and performed as intended.There were no device deficiencies.A cook safe-t-j rosen catheter exchange wire guide, rpn: thscf-35-260-1.5-rosen was used in the contralateral access site to access the renal artery.The device successfully targeted the vasculature and performed as intended.There were no device deficiencies.An angiogram and a cone beam computed tomography scan was performed 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 1b endoleak on the most distal aortic component was identified.There were no stent graft integrity issues.All target side branch stents were intact.The stent integrity issue did not lead to any medical problems or adverse events.Side branch catheterization and placement of all bridging stents was successful.No additional procedures were performed during the custom made device (cmd) procedure.The patient did not have any significant medical problems or complications during the study procedure.No stents overlapped between distal device and arch device proximal to it as no distal device was placed.2.0 to 2.9 stents overlapped between distal device and an additional distal device.The overlap between distal device and additional distal device was not bridged with an additional tevar device.There was a ¿failed connection between the left iliac component and the distal aortic bifurcated graft.On 15apr2024 the patient did not have a left groin pulse.An attempted endovascular bailout was unsuccessful.A femoral-to-femoral bypass was required.The lack of perfusion was due to a procedural failure, where the contralateral limb was unable to be cannulated.The intervention was considered successful.The patient recovered/stabilized without sequelae.The patient will be followed in the study follow up program.The subject of this report is the type 3a endoleak on the zenith flex with spiral-z technology aaa endovascular graft iliac leg that was discovered during procedural imaging on (b)(6) 2024.
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Additional information: d4 (model) investigation evaluation cook was notified that during a fenestrated endovascular aortic repair (fevar) procedure on (b)(6) 2024, procedural imaging identified a type 3a endoleak on the left contralateral zenith flex with spiral-z technology aaa endovascular graft iliac leg.The patient underwent a procedure on (b)(6) 2024 under general anesthesia.Percutaneous access was achieved in the left and right femoral arteries.An endovascular iliac conduit was performed at the time of the procedure.During the procedure competitor¿s stents were placed in the celiac, superior mesenteric, right renal, and left renal arteries.A cook custom made device; a thoracic proximal extension was placed.Additionally, a cook distal body was placed.Bilaterally, the iliac arteries had zenith flex with spiral-z technology aaa endovascular graft iliac legs placed.The patient did not have any significant medical problems or complications during the study procedure.An angiogram and a cone beam computed tomography scan was performed 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 1b endoleak on the most distal aortic component was identified.There were no stent graft integrity issues.All target side branch stents were intact.The stent integrity issue did not lead to any medical problems or adverse events.Side branch catheterization and placement of all bridging stents was successful.No additional procedures were performed during the custom-made device (cmd) procedure.No stents overlapped between distal device and arch device proximal to it as no distal device was placed.2.0 to 2.9 stents overlapped between distal device and an additional distal device.However, there was a ¿failed connection between the left iliac component and the distal aortic bifurcated graft.On (b)(6) 2024 the patient did not have a left groin pulse.An attempted endovascular bailout was unsuccessful.A femoral-to-femoral bypass was required.The lack of perfusion was due to a procedural failure, where the contralateral limb was unable to be cannulated.The intervention was considered successful.The patient recovered/stabilized without sequelae.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.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 did not reveal any non-conformances.A complaint history search did not identify any other events reported for a related failure mode.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Imaging was provided for the investigation.The image reviewer noted this was a complicated case.The patient had undergone a previous thoracic endovascular aortic repair (tevar) as well as an open repair.During the open repair a 16 mm or 18 mm diameter open graft most likely was placed.Therefore, the access was restricted and tight, unlike inside an aneurysm.Additionally, the patient had a previous thoracic endovascular aortic repair.This would have provided little room to maneuver when trying to cannulate the contralateral limb of the cook device.The image reviewer indicated the main problem was very tight access inside a previously placed graft in a previous open repair.This resulted in operator error as a procedural problem.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: ¿4 warnings and precautions.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.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 sheaths.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.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 enhances follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components or stent fracture) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.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 (table 10.5.1).Appropriate device oversizing has been incorporated into the ifu sizing guide.Sizing outside of this range can result in endoleak, fracture, migration, device infolding and compression.4.5 implant procedure appropriate procedural imaging is required to successfully position the zenith spiral-z aaa iliac leg and assure accurate apposition to the vessel wall.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, bleeding, hematoma or coagulopathy, 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; perigraft flow; and corrosion.7.1 individualization of treatment additional considerations for patient selection include, but are not limited to: risks and differences between endovascular repair and surgical repair 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 the 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.Physician 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 pre-implant determinants verify from pre-implant planning that the correct devices has been selected.Determinants include: 1.Femoral artery selection for introduction of the delivery system (i.E., define respective contralateral and ipsilateral iliac arteries) 2.Angulation of aortic neck, aneurysm and iliac arteries 3.Diameters of infrarenal aortic neck and distal iliac arteries.4.Length from the aortic bifurcation of a previously placed main body or renu form the zenith aaa endovascular graft family of products to the internal iliac arteries/attachment site(s).5.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.6.Degree of vascular calcification final angiogram 1.Position 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 kinks 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.3.Repair vessels and close in standard surgical fashion 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.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 critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.Physicians should evaluate patients on an individual basis 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, inspection of the returned device, and the results of the investigation, a definitive root cause for this event could not be established.It is possible the procedure itself contributed to the failure mode due to the tight access from a previous open repair with very little room to maneuver to cannulate the contralateral limb.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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