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Additional information: h6- annex a.Investigation / evaluation: a cook representative from (b)(6) center in the united states informed cook on 17feb2021 of an incident involving multiple cook devices.It was reported that the patient presented emergently to (b)(6) hospital on (b)(6) 2021 with a ruptured aneurysm and an abdomen full of blood clots.Separation had occurred between the main body graft and the ipsilateral leg graft.The physician clamped 2cm above the renal arteries to place an extension graft; however, there was no blood flow below the aorta and all grafts were completely thrombosed.The intervention procedure was not successful, and the patient expired.The 78-year-old male patient underwent an endovascular aneurysm repair (evar) procedure to treat an abdominal aortic aneurysm (aaa) on (b)(6) 2010 at (b)(6) hospital.A main body tffb-30-111-zt (lot: 2528519), proximal contralateral tfle-12-90-zt (lot: 2376696), distal contralateral tfle-18-73-zt (lot: 2459967) and an ipsilateral tfle (rpn: unknown) were implanted.It was also reported that the patient presented back to (b)(6) hospital and the physician approximately 2 years ago due to a disconnection and blood clots between the main body graft and one of the iliac leg grafts.On (b)(6) 2019, the patient underwent an additional procedure and the physician placed a zsle extension graft to bridge the separation area.Per the family reporting the most recent events, this physician stated this would occur again and would be very bad when it does.A review of documentation including the complaint history, device history record (dhr), drawing, instructions for use (ifu), specificaions, and quality control of the device, as well as a visual inspection of returned imaging and dimensional verification, was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, ct and angiography studies dated on (b)(6) 2019 and on (b)(6) 2021 were provided for evaluation and sent for expert image review.This investigation focuses on the reported thrombus occlusion and graft separation from the proximal left (contralateral) zsle-9-122-zt, lot: 9127512xx.Review of the imaging provided confirmed the reported thrombus occlusion of the left zsle-9-122 graft.On the last ct (date anonymized to on (b)(6) 2021, likely the reported date on (b)(6) 2021), the right tfle (likely tfle-24-71 based on imaging measurements) was completely separated from the tffb-30-111 ipsilateral limb, all graft components were completely thrombosed, and there was a massive retroperitoneal hematoma consistent with aortic rupture.The reported blood clots observed at the secondary intervention procedure on (b)(6) 2019 were not observed on the imaging provided.The zsle-9-122-zt graft was implanted during the secondary procedure on (b)(6) 2019 as a distal extension into the left external iliac artery to treat a type 1b endoleak.Contributing factors identified for the thrombus formation observed within the left zsle graft included severe hypotension and a low flow state following the aaa rupture.The reviewer stated, "following the rupture, the aaa sac appears to have thrombosed, likely due to severe hypotension and a low-flow state, and this may have led to outflow obstruction of the ipsilateral limb and thrombosis of the main body graft.The acute loss of flow then led to thrombosis of the left leg grafts and loss of collateral flow from bilateral iliac systems.It is unclear if the disconnected right tfle leg was previously occluded or if this occurred acutely with the other components." the imaging reviewer observed a possible type 1a endoleak on the 125-month cta resulting from a complete lack of sealing stent apposition within the proximal neck.The type 1a endoleak was not definitively confirmed due to complete thrombosis of the endograft and aaa sac.The investigation referenced under report reference#: 1820334-2021-00937 notes the reviewer's finding of a type 1a endoleak on the tffb-30-111 graft.The reported separation of the proximal left tfle-12-90-zt from the tffb contralateral limb was not observed on the imaging provided.Based on review of the secondary intervention imaging, a type 1b endoleak was observed on the distal left tfle-18-73-zt and treated with placement of the zsle-9-122-zt.Report reference#: 1820334-2021-00940 captures the tfle-18-73-zt type 1b endoleak.After placement of the zsle-9-122-zt, the reviewer noted a type 3a endoleak between the overlap of both components.Report reference#s: 1820334-2021-00940 (tfle-18-73-zt) and 1820334-2021-00942 (zsle-9-122-zt) provided investigation results based on this finding.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify potential nonconformances prior to distribution.A review of the design history file (dhf) showed that the affected product is safe and effective for its intended use.A review of the device history record (dhr) for lot: 9127512xx found no related nonconformances that could have contributed to the reported failure mode.As the zsle-9-122-zt is a one-device lot, it should be noted that there were no other complaints associated with this lot number.There were no related nonconformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field.Therefore, cook concluded there is no evidence that nonconforming product exists either in house or in field.Based on the information provided, review of post-operative imaging and review of current documentation regarding controls and inspections, cook has concluded that the product was manufactured to specification.The complete thrombus occlusion of the left zsle graft greater than 10 years post implantation was likely secondary to the aaa rupture.The instructions for use (ifu) for [t_zaaasz_rev3] ¿zenith® spiral-z aaa iliac leg with the z-trak¿ introduction system¿, provides the following information related to the reported failure mode: "4 warnings and precautions: 4.1 general: additional endovascular interventions or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and 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: 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.Patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.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.These sizing measurements are critical to the performance of the endovascular repair.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.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.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: systemic anticoagulation should be used during the implant procedure based on hospital- and physician-preferred protocol.If heparin is contraindicated, an alternative anticoagulant should be considered.Use caution during manipulation of catheters, wires and sheaths within an aneurysm.Significant disturbances may dislodge fragments of thrombus, which can cause distal embolization, or may rupture the aneurysm.Excessive overlap 10 mm above the main body bifurcation may increase the risk of limb thrombosis.Inaccurate placement and/or incomplete sealing of the zenith spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.5 adverse events: 5.2 potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: arterial or venous thrombosis and/or pseudoaneurysm.Claudication (e.G., buttock, lower limb).Embolization (micro and macro) with transient or permanent ischemia or infarction endoprosthesis: occlusion.Graft or native vessel occlusion.Renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure).Endoleak.Endoprosthesis: graft material wear; erosion; puncture.7 patient selection and treatment: 7.1 individualization of treatment: the risks and benefits should be carefully considered for each patient before use of the zenith spiral-z aaa iliac leg.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) the final treatment decision is at the discretion of the physician and patient.8 patient counseling information: 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¿ device-related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture and death.11 directions for use: anatomical requirements: iliofemoral access size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories.Arterial conduit techniques may be required.11.1 zenith spiral-z aaa iliac leg system: 11.1.4 contralateral iliac leg placement and deployment: 3.Introduce the contralateral iliac leg delivery system into the artery.Advance slowly until at least one stent of the iliac leg graft overlaps within the main body and not past the radiopaque marker band positioned 30 mm from the proximal end of the iliac leg graft inside the contralateral limb of the main body.If there is any tendency for the main body graft to move during this maneuver, hold it in position by stabilizing the gray positioner on the ipsilateral side.4.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency, a minimum overlap of one stent, and a maximum overlap of 30 mm within the main body endovascular graft.11.1.5 ipsilateral iliac leg placement and deployment: note: if using this device in conjunction with a zenith alpha abdominal endovascular graft or zenith low profile endovascular graft, proceed to section 11.1.16, ipsilateral iliac leg placement and deployment in conjunction with zenith alpha abdominal endovascular graft or zenith low profile endovascular graft.For all other systems, continue with steps 1-7 below.2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one stent inside the ipsilateral limb of the main body.3.Confirm position of distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency.11.1.6 ipsilateral iliac leg placement and deployment in conjunction with zenith alpha abdominal endovascular graft or zenith low profile endovascular graft 4.Introduce the ipsilateral iliac leg delivery system, and continue advancing slowly until the proximal edge of the ipsilateral leg graft aligns with the proximal edge of the previously-placed contralateral leg graft.5.Confirm position of the distal end of the iliac leg graft.Reposition the iliac leg graft if necessary to ensure internal iliac patency.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.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.Final angiogram: 1.Position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kinks and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components.12 imaging guidelines and postoperative follow-up 12.1 general 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." based on the information provided, no returned product, and the results of our investigation, it was concluded that the cause can be traced to an adverse event related to the patient's condition.It was determined that the separation of the zsle-9-122-zt from the tfle-18-73-zt was likely caused by disease progression.The complete thrombus occlusion of the left zsle graft greater than 10 years post implantation was likely secondary to the aaa rupture.The conclusions of related investigations determined that this was primarily caused by aneurysm expansion from continued disease progression over the postoperative time interval.Thrombus, endoleaks, and component separation are known inherent risks of the device detailed in the product ifu.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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