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Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation evaluation it was reported that after an emergency endovascular aaa repair, there was blood leakage (an endoleak) through a zenith flex with spiral-z technology aaa endovascular graft iliac leg where the graft was sutured on either side.A main body graft was implanted into a 62 year old male patient along with three zenith flex with spiral-z technology aaa endovascular graft iliac legs.An angiogram was performed at the end of the case and confirmed no leaks were evident.About 5 hours later it was reported that the patient's blood pressure was dropping, and this was assumed to be due to a leak.More angiograms were performed but could not confirm the presence of any leaks.During this time, the patient's blood pressure continued to drop.The doctor decided to surgically open up the abdomen to locate the source of the bleeding.The doctor found "the blood coming through the graft material through the limbs where the graft was sutured on both sides".Two more zenith legs were added to cover the entire limb on both sides.The piece added on the left iliac helped to resolve the issue but the piece on the right iliac did not.The doctor then decided to add a competitor's stent to the right iliac limb where the bleeding was observed, which resolved the issue.There was no calcification present in the vessels containing the grafts.The patient was given heparin intraoperatively but the patient was coagulopathic.A 32coda balloon was inflated with a 30cc syringe, and the ballooning was done in the proximal and distal seal zones and graft overlap bilaterally.The main body was implanted up the right iliac and deployed in the aorta just below the renal arteries.The graft was fully deployed and the introducer was removed so the right common iliac graft could be placed and a coda balloon could be inserted and expanded in the graft to occlude the aorta.A zsle-13-90-zt was placed in the right common iliac.The contralateral gate was selected and a zsle-13-74-zt was placed followed by a zsle-16-74-zt into the left common iliac.A review of the documentation, complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation.The complaint devices were not returned for evaluation, and no imaging was provided for expert review.Additionally, a document based investigation evaluation was performed.A review of the device master records found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history files found that the affected products are safe and effective for theirintended use.A review of the device history records found no nonconformances or additional complaints associated with these device lots.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 devices were 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; 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 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, no inspection of the products and the results of the investigations, a definitive cause for failure was not established.With the limited information provided in the complaint with the information provided indicating the resolution of the endoleak after relining with additional stent grafts, it can be narrowed down that the source of the endoleak was most likely a type iiib (hole or tear in graft material) endoleak.It was stated within the complaint that the leakage was coming through the graft material through the limbs where the graft was sutured on both sides.This type of endoleak can typically arise from stretched suture holes possibly due to overballooning.However, the balloon was properly inflated with a 30cc syringe, and the ballooning was done in the proximal and distal seal zones and graft overlap bilaterally.So it is not particularly identifiable what would have caused this.The physician did mention that this patient was coagulopathic and heparin was used intraoperatively.It is feasible to suggest that perhaps this heparin use for anticoagulation could have potentially contributed to the report leakage.Nonetheless, endoleaks are a known inherent risk with any endovascular procedure.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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