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It was reported that on (b)(6) 2015, under local anesthesia, the clinical study patient received a main-body graft (zalb-28-108-ci, lot #5079291), an ipsilateral (right) iliac leg graft (zsle-16-74-zt, lot #5782447), and a contralateral (left) iliac leg graft (zsle-16-56-zt, lot #5759274).The site noted difficulty deploying the main body and noted ¿trigger wire used a lot of force to remove¿.Bilateral iliac angioplasty with a non-compliant balloon was performed within the graft after graft deployment.A molding balloon was used without complications or difficulties.At the completion of the procedure, the graft was fully implanted and patent with no endoleaks or kinks.The patient has been followed with serial computerized tomography (ct) scans (dates (b)(6) 2015, (b)(6) 2015, (b)(6) 2016, (b)(6) 2017, and (b)(6) 2018).All have reported a patent, intact device with no report of an endoleak or kink (as reported by both the clinical site and core lab).On (b)(6) 2019, the patient had a secondary intervention for a reported type i distal endoleak in the left iliac leg graft.The site stated ¿small type 1b endoleak secondary to aneurysmal degeneration of the left common iliac artery.Aortic endograft with left iliac artery extender (gore plc1214001) placement and hypogastric artery coil embolization.The patient was discharged from the hospital the day after the secondary intervention." the secondary intervention was reported to be successful.The patient has completed 3 years of the 5 year study.
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Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use, quality control, as well as a visual inspection of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination of the device was unable to be performed.However, imaging in the form of a ct, angio and x-ray dating from 23mar2015 to 16jan2019 was returned for expert image review.Pre-implantation and follow-up ctas at 1, 6, 12, 24 and 36 months were provided, as well as implantation and 42-month secondary intervention angiography.Six- and 12-month x-rays were also provided.Per the findings of the image review, the complaint was not confirmed, as contrast extension between the left zsle sealing stent and the common iliac artery (cia) slowly progressed through 26 months.Because it did not communicate with the aneurysm sac, it did not represent an endoleak.The extension initially enlarged because of increased iliac tortuosity.Slowed but progressive growth afterwards indicated degeneration intrinsic to the left cia.A type ib endoleak may have eventually developed.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The design verification testing performed showed that the affected product is safe and effective for its intended use.A review of the device history record showed one nonconformance in lot 5759274 for discoloration, however, this was reworked to specification prior to qc release.It was determined that the discoloration would not have played a role in contributing to or causing the reported endoleak for this device.It should be noted that there were no other complaints reported for lot 5759274.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user 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 folling 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; please see section.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 endorposthesis may require surgical intervention.11.1.7 molding balloon insertion: 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) withdraw the molding balloon to the ipsilateral limb overlap region and expand.Withdraw the molding balloon to the ipsilateral distal fixation site and expand.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.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation site and expand.(fig.15).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, no product returned and the results of our investigation, a definitive root cause could not be traced to the device, but rather to an adverse event related to the patient condition.Although the returned expert image review does not confirm the type ib endoleak, an endoleak is defined as a persistent blood flow outside of an endoluminal graft, but this endoleak did not communicate with the aneurysmal sac.Per the image review, ¿contrast extension between the left zsle sealing stent and the cia slowly progressed through 36 months [¿] [but] it did not communicate with the aneurysm sac.[¿] the extension initially enlarged because of increased iliac tortuosity.Slowed but progressive growth afterwards indicated degeneration intrinsic to the left cia.¿ as a result, a definitive investigation conclusion has been determined to be due to patient anatomy and disease progression.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified and we 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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