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It was reported in a literature article that a zenith flex with spiral-z technology aaa endovascular graft iliac leg contributed to a type 1b endoleak in a patient, resulting in rupture of the aneurysm and death.A (b)(6) year old man with a 64mm juxtarenal abdominal aortic aneurysm was repaired in april 2013 using a cook 32x124 mm proximal main body with bilateral renal artery fenestrations and an sma scallop in a 20x45x76 mm configuration.Junctional overlap was 55 mm and no endoleaks were noted at the first post-op visit.Aortic anatomy remained stable until 18 months post-op.At 18 months post-operation, a contrasted computed tomography (ct) demonstrated residual sac enlargement to 69 mm.Aortic duplex did not show any evidence of endoleak.At 24 months post-operation, repeat cta showed continued sac expansion to 74 mm with a decrease in modular overlap to 50 mm.Aortic duplex did not show any flow to the residual sac.The patient opted to continue noninvasive imaging and defer a diagnostic angiogram.At 36 months post-operation, his residual sac was stable without endoleak evidence.Continued decrease in junctional overlap to 37 mm secondary to progressive angulation of the distal sac was unrecognized.The decision at this point was to continue follow-up surveillance without intervention.At 45 months post-operation, the patient presented at an outlying hospital with sudden, severe abdominal pain in the setting of profound hypotension.Cta demonstrated increased sac size to 93 mm with evidence of retroperitoneal hematoma and acute rupture.The right iliac limb had retracted secondary to continued distal aneurysmal degeneration, creating a large type1b endoleak resulting in sac pressurization and progressive migration of the distal bifurcated graft.The separation of the zenith fenestrated grafts are reported in mdr: 9680654-2017-00003 and mdr:9680654-2017-00004.Please note that zenith fenestrated aaa endovascular grafts are not sold in the us and there is not a similar device that is sold in the us.The patient quickly became unresponsive despite initiation of massive transfusion protocols.The family decided to initiate comfort measures and withdraw heroic measures, and the patient passed away on (b)(6) 2017.
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Investigation/evaluation: dr.(b)(6) from (b)(6) hospital of in, inc notified cook on 18feb2020 of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (zsle-13-74-zt) from lot number: 3802786.A 63-year-old man with a 64mm juxtarenal abdominal aortic aneurysm (aaa) presented for an endovascular aneurysm repair (evar) procedure on (b)(6) 2013 using a 32x124mm proximal main body with bilateral renal artery fenestrations and an sma scallop in a 20x45x76 mm configuration.Junctional overlap was 55 mm and no endoleaks were noted at the first post-op visit.Aortic anatomy remained stable until 18 months post-op.It was reported that at, 45 months post-op the patient presented at an outlying hospital with sudden, severe abdominal pain in the setting of profound hypotension.Cta demonstrated increased sac size to 93 mm with evidence of retroperitoneal hematoma and acute rupture.The right iliac limb had retracted secondary to continued distal aneurysmal degeneration, creating a large type ib endoleak resulting in sac pressurization and progressive migration of the distal bifurcated graft.The patient quickly became unresponsive despite initiation of massive transfusion protocols.The family decided to initiate comfort measures and withdraw heroic measures, and the patient passed away on (b)(6) 2017.A review of the documentation, complaint history, device history record, instructions for use (ifu), and quality control, as well as a visual inspection of imaging provided were conducted during the investigation.The complaint device was returned not available for evaluation but imaging was provided in a related complaint and sent for expert review.The image review found that the proximal and distal components of the endograft opened up at the junction between the two parts, contributing to a type iii endoleak that was observed in the imaging provided in the journal article.A very marked anterior "bowing" of the graft with separation of components was noted.It is unknown if the patient's aorta was very tortuous at the time the endograft was inserted, but the image reviewer felt this was likely to be the case.The graft itself was inside an aneurysm with a fairly small amount of thrombus, meaning that the graft could bow even more with no restriction by organized thrombus.There was no defect noted in the graft itself or its design.No type ib endoleak was confirmed from image review, but it is possible that the type iiia endoleak contributed to the type ib endoleak noted at 45 months post-operation.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the affected product line remains safe and effective for its intended use.A review of the device history record found no related nonconformances or additional complaints associated with this device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: 4.2 patient selection, treatment and follow-up zenith spiral-z iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a main body or renu from the zenith aaa endovascular graft family of products, refer to the appropriate instructions for use.4.2 patient selection, treatment and follow-up zenith spiral-z iliac artery distal fixation site greater than 10mm in length and 7.5-20mm in diameter (measured outer wall to outer wall) is required.These sizing measurements are critical to the performance of the endovascular repair for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a main body or renu from the zenith aaa endovascular graft family of products, refer to the appropriate instructions for use.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 17 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis and/or increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.The zenith spiral-z aaa iliac leg has not been explicitly evaluated clinically; however, its performance is represented by the zenith aaa endovascular graft iliac leg (a previous version of the device), which has not been evaluated in the following patient populations: key anatomical elements that fall outside the sizing requirements specified in the appropriate main body or renu instructions for use successful patient selection requires specific imaging and accurate measurements; 4.3 pre-procedure measurement techniques and imaging diameters utilizing ct, diameter measurements should be determined from the outer wall to outer wall vessel diameter (not lumen measurement) to help with proper device sizing and device selection.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 or compression.4.5 implant procedure: 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.Inadequate fixation of the zenith flex aaa endovascular graft may result in increased risk of migration of the stent graft.Incorrect deployment or migration of the endoprosthesis may require surgical intervention.11.1.7 molding balloon insertion: 5.Expand the molding balloon with diluted contrast media (as directed by the manufacturer) in the area of the most proximal covered stent and the infrarenal neck, starting proximally and working in the distal direction.(fig.15) 6.Withdraw the molding balloon to the ipsilateral limb overlap region and expand.7.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.8.Deflate and remove molding balloon.Transfer molding balloon onto the contralateral wire guide and into the contralateral iliac leg introduction system.Advance molding balloon to the contralateral limb overlap and expand.9.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.(fig.15) 10.Remove molding balloon and replace it with an angiographic catheter to perform completion angiograms.12.3 abdominal radiographs: the following views are required: four films: supine-frontal (ap), cross-table lateral, 30 degree lpo and 30 degree rpo views centered on umbilicus.Record the table-to-film distance and use the same distance at each subsequent examination ensure entire device is captured on each single image format lengthwise.If there is any concern about the device integrity (e.G.Kinking, stent breaks, barb separation, relative component migration), it is recommended to use magnified views.The attending physician should evaluate film for device integrity (entire device length including components) using 2-3x magnification visual aid.12.6 additional surveillance and treatment: additional surveillance and possible treatment is recommended for: aneurysms with type i endoleak.Aneurysms with type iii endoleak.Aneurysm enlargement, =5 mm of maximum diameter (regardless of endoleak status) migration.Inadequate seal length: consideration for reintervention or conversion to open repair should include the attending physician's assessment of an individual patient's co-morbidities, life expectancy and the patient's personal choices.Patients should be counseled that subsequent reinterventions including catheter based and open surgical conversion are possible following endograft placement.Based on the information provided, inspection of the imaging provided, and the results of the investigation, a definitive cause for the endoleak was not established, however endoleaks are a known inherent risk of these devices.It is possible that graft sixing or migration, as well as patient-related factors such as angulation of the aneurysm, disease progression, and/or presence of thrombus could have contributed to the reported incident.The appropriate personnel have been notified.Per the quality engineering 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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