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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex a.Investigation ¿ evaluation: it was reported that a patient experienced compression at the right iliac limb graft.The complaint device was zenith flex with spiral-z endovascular graft iliac leg.On (b)(6) 2023, percutaneous access was obtained in the right and left femoral arteries.Fusion was used during the procedure.The estimated blood loss was 100 ml.There was no cardiac output reduction; carbon dioxide flushing was not used.The proximal seal zone was the native aorta.Near-infrared spectroscopy (nirs) was used in the procedure.All stent grafts and intended side branch stents were patent as well as target vessels at the conclusion of the procedure, confirmed via angiogram.Iliac kissing was performed but was unplanned.There were no technical difficulties and considered successful in the delivery and deployment of the custom-made device cook pre-loaded-fenestrated-prox.Renal components were implanted in the left and right renal arteries.Two cook distal aortic devices, zenith iliac leg graft devices, were placed during the procedure and was considered a technical success without difficulty.Procedural imaging (cone beam ct with contrast) was completed.No endoleak was present at the conclusion of the procedure, confirmed via angiogram and cone beam ct.However, there was evidence of stent graft integrity issues at the conclusion of the procedure.The barb was bending, and barb separation was identified.Device compression occurred in the most proximal left iliac limb and the most proximal right iliac limb.All target side branch stents were intact.More than or equal to 3 stents overlap was present between the distal device arch device proximal to it.The overlap between the distal device and arch graft was not bridged with an additional tevar device.The overlap between the distal device and additional distal device was 1 to 1.9 stents.This overlap was not bridged with an additional tevar device.The patient required the placement of iliac kissing stents during the procedure due to the device compression.The patient was prescribed aspirin (salicylic acid) therapy at the time of the procedure.It was reported the patient had a previous thromboembolic event, peripheral vascular disease (pvd), and hypertension.No information has been provided at this time about if the stent graft device compression lead to any medical problems or adverse events.The patient was discharged from the hospital on (b)(6) 2023.No supplemental oxygen, no anticoagulant was prescribed but the patient did receive statin, clopidogrel and acetylsalicylic acid (asa).Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) of the complaint device were conducted during the investigation.The complaint device was not returned for investigation; therefore, no physical examination could be conducted.However, medical imaging was provided by the customer for expert review.The complaint of iliac leg compression is not confirmed.The iliac legs were not externally compressed on the spin angiogram.The cone beam ct reconstructions that may have demonstrated compression were not provided.The narrowed distal aorta increased the risk of limb compression.Rapid additional stent implantation indicates that narrowing was likely.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 relevant non-conformances.A database search did not identify any other complaints associated with the reported device lot.Cook also reviewed product labeling.The ifu t_zaaasz_rev4 packaged with the device contains the following in relation 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: ¿ 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) is required.Theses 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 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.¿ successful patient selection requires specific imaging and accurate measurements; please see section 4.3, pre-procedure measurement techniques, and imaging.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 the zenith spiral-z aaa iliac leg.If contrast-enhanced spiral zta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.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.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 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 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.¿ 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.¿ avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.5.2 potential adverse events: ¿ claudication (e.G., buttock, lower limb).¿ 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.¿ surgical conversion to open repair.7.1 individualization of treatment.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.¿ 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).8 patient counseling information: ¿ 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 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 is required and should be considered a life-long commitment to the patient¿s health and well-being.¿ physicians must advise all patients 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).11 directions for use: ¿ 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.12 imaging guidelines and postoperative follow-up: 12.1 general: ¿ the long-term performance of endovascular grafts with secondary endovascular intervention using additional components 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 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 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., pain, numbness, weakness).Patients with specific clinical findings (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm 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." a pre-procedure cta (2.5 months prior to the procedure) and an angiography completed during the implant procedure were reviewed for the investigation.The image reviewer indicated "1.The complaint of iliac leg compression is not confirmed.The iliac legs were not externally compressed on the spin angiogram.The cone beam ct reconstructions that may have demonstrated compression were not provided.2.The narrowed distal aorta increased the risk of limb compression.3.Rapid additional stent implantation indicates that narrowing was likely anticipated." 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.Based on the information provided, expert review of medical imaging provided by the facility, and the results of our investigation, cook could not establish a definitive cause for the reported failure.And while the cause is not known, patient anatomy likely contributed to this incident.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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