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Investigation - evaluation: a review of documentation including the complaint history, device history record, instructions for use (ifu) and quality control of the device was conducted during the investigation.Physical evaluation of the device could not be performed, as the device was not returned for investigation.However, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify potential nonconformances prior to distribution.Design validation testing showed that the affected product is safe and effective for its intended use.A review of the device history record for lot 7385255 found no relevant nonconformances that could have contributed to the failure mode.It should be noted that there have been no other complaints reported for this lot number.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: 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.12.2 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.¿ ¿contraindications, patients with a systemic infection may be at increased risk of endovascular graft infection.¿ ¿patient selection, treatment and follow-up, the zenith universal distal body has not been evaluation the following patient populations¿ patients with active systemic infections.It is unknown when the patient acquired the infection, prior to the initial fevar, during the procedure, or after the initial procedure.It would be assumed that the procedure would not have taken place if this was detected prior to the initial procedure.¿the zenith sprial-z aaa iliac leg has not been explicitly evaluated clinically; however, its performance is represented by the zenith aaa endovascular graft iliac let (a previous version of the device), which has not been evaluation in the following patient populations¿¿.Patients with active systemic infections.¿ ¿implant procedure requirements, minimize handling of the constrained endoprosthesis during preparation and insertion to decrease the risk of endoprosthesis contamination and infection.¿ ¿potential adverse events, vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula¿¿wound complications and subsequent attendant problems (e.G., dehiscence, infection)¿.Based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established.Endoleaks are a known inherent risk of the device.Infection is a potential adverse effect of the use of this device.Infection is also a risk when undergoing any surgical procedure and while being hospitalized pre and post-surgical procedure.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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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