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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.Cook became aware of a 77-year-old male patient where the graft clotted off completely below the renal and into the legs.The date of the original procedure was (b)(6) 2021 and rpn: tffb-30-82-zt (product lot 13323564) was implanted.The surgeon performed a cut down on the groins.Pre-angioplasty balloons and dilators were used in iliac vessels due to disease being present.There were no difficulties during the procedure.The only observation under scanning was thrombosis below the renal all the way down to the femora.The suprarenal stent was not explanted with the graft and remained inside the patient¿s body.Pre-operative and post-operative imaging were requested but only post-operative was provided.The patient did not have any pre-existing conditions or comorbidities in addition to the procedure.It was reported the patient received the covid johnson & johnson vaccination and the physician feels that could have something to do with this event.There is an additional procedure required due to this occurrence.The date for the follow-up procedure is unknown.It was reported that the patient is doing well post-explant.A review of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures of the device were conducted during the investigation.The complaint deceive was not returned to cook for analysis.Post-operative imaging (after evar, but prior to open repair and explant) was provided by the customer.The suprarenal aorta appears to measure 22 mm outer diameter.The immediate infrarenal aorta measures approximately 26 mm.The distal lumen of both zsle devices appear to measure 6-7 mm.Component oversizing may have caused redundancy of graft material but difficult to tell without pre-operative imaging to evaluate.The tffb main body appears to be occluded approximately 2.5 cm distal to the inferior renal artery with bilateral limb occlusions.Additionally, a document based investigation evaluation was performed.Review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failure.Cook reviewed the device history record for the final product and the subassembly work orders.The final lot 13323564 had one nonconformance, but it was reworked and re-inspected prior to further processing.A database search found no additional complaints on the lot.Because there were no additional nonconformance¿s on this lot and no other complaints have been reported.Cook concludes that the complaint device was manufactured per specification.The device was packaged with ifu t_zaaaf_rev5.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.4 warning 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 an enlarging aneurysm, 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 key anatomical elements that may affect successful exclusion of the aneurysm include sever proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.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 16 french to 22 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.The zenith flex aaa endovascular graft 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.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 clinical experience indicates that contrast-enhanced spiral computed tomographic angiography (cta) with 3-d reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy prior to treatment with zenith flex aaa endovascular graft.If contrast-enhanced spiral cta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.The long-term performance of endovascular grafts has not yet been established.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.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.4.4 device selection strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).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 do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.Inaccurate placement and/or incomplete sealing of the zenith flex aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.Fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.5 adverse events 5.2 potential adverse events claudication (e.G., buttock, lower limb) graft or native vessel occlusion.7 patient selection and treatment co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity) patient¿s anatomical suitability for endovascular repair iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 16 french to 22 french vascular introducer sheath 8 patient counseling information the long-term performance of endovascular grafts has not yet been established.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.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative 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 are required and should be considered a lifelong commitment to the patient¿s health and well-being.Physicians must advise each patient that it is important to seek prompt medical attention if they experience signs of limb occlusion, aneurysm enlargement or rupture.Signs of graft limb occlusion include pain in the hip(s) or leg(s) during walking or at rest or discoloration or coolness of the leg.Aneurysm rupture may be asymptomatic, but usually presents as: pain; numbness; weakness in the legs; any back, chest abdominal or groin pain; dizziness; fainting; rapid heartbeat or sudden weakness.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 (see section 5.1, observed adverse events and section 5.2 potential adverse events).The physician should complete the patient i.D.Card and give it to the patient so that he/she can carry it with him/her at all times.The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures (e.G., mri).12 imaging guidelines and postoperative follow-up 12.1 general.The long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and 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 a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment aaas.Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.The recommended imaging schedule is presented in table 12.1.1.This schedule was used in the pivotal trial and is recommended 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.The combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.Duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak, patency, tortuosity, and progressive disease.In this circumstance, a non-contrast ct should be performed to use in conjunction with the ultrasound.Ultrasound may be a less reliable and sensitive diagnostic method compared to ct.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Evidence provided by the complaint facility, device failure analysis, device history record, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.A definitive cause for the reported failure could not be established.And while the cause in this case is not known, it is possible that the patient anatomy, preexisting conditions, or medical procedure may have contributed to this event.The appropriate internal personnel have been notified.Per the 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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