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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: (b)(6) hospital informed cook of an incident involving a zenith flex aaa endovascular graft bifurcated main body (tffb-28-96-zt) lot 7019328.The 74-year-old male patient was treated on (b)(6) 2018 by evar (endovascular aneurysm repair) for an emergency rupture by a previous surgeon.The patient¿s current surgeon has discovered an endoleak of unknown origin.Initially, it was thought to be a type 2 endoleak but due to the increasing sac size, the surgeon now believes it may by a type 3 endoleak from the graft fabric near the bifurcation.The surgeon has requested a custom-made device to reline the graft.The reintervention is expected to take place in june but, an exact date has not been provided.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complainant did not return the complaint device to cook for evaluation.However, imaging was provided and reviewed by an expert reviewer.The reviewer noted ¿there is an endoleak in the vicinity of the bifurcation of the tffb aaa graft, and this can be seen in the axial view and the sagittal view.The exact origin of the endoleak is not clear on any of the views, but certainly appears to be arising at the bifurcation.There is no lateral stress at the bifurcation that would have caused tearing of the graft fabric ¿ the two limbs are lying parallel ¿ so i am not sure as to the cause of the endoleak.However, i can¿t see any evidence of any other cause, eg type 2 endoleaks from either the ima or lumbar vessels.It most likely arises from the device in the vicinity of the bifurcation, so i would call it a presumed type 3 endoleak.¿ additionally, a document-based investigation evaluation was completed.A review of the device master record (dmr) concluded based on the current documentation that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for lot 7019328 recorded no non-conformances related to this incident.There are no additional complaints on the lot.Cook also reviewed product labeling.The product ifu, t_zaaaf_rev 4 ¿zenith flex aaa endovascular graft with the z-trak introduction system,¿ provides the following information to the user 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 an enlarging aneurysm, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak or migration may lead to aneurysm rupture.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.The zenith flex aaa endovascular graft is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith flex aaa endovascular graft is designed to treat proximal aortic necks (distal to the lowest renal artery) of at least 15 mm in length.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.Key anatomical elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation (>60 degrees for infrarenal neck to axis of aaa or >45 degrees for suprarenal neck relative to the immediate infrarenal neck); short proximal aortic neck (<15 mm); an inverted funnel shape (greater than 10% increase in diameter over 15 mm of proximal aortic neck length); and circumferential thrombus and/or calcification at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.In the presence of anatomical limitations, a longer neck may be required to obtain adequate sealing and fixation.Irregular calcification and/or plaque may compromise the attachment and sealing at the fixation sites.Necks exhibiting these key anatomical elements may be more conducive to graft migration or endoleak.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 16 french to 22 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.Multiple large, patent lumbar arteries, mural thrombus and a patent inferior mesenteric artery may all predispose a patient to type ii endoleaks.Patients with uncorrectable coagulopathy may also have an increased risk of type ii endoleak or bleeding complications.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.The contrast-enhanced spiral ct scan must start 1 cm superior to the celiac axis and continue through the femoral heads at an axial thickness slice of 3 mm or less.4.4 device selection: strict adherence to the zenith flex aaa endovascular graft ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.2).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: appropriate procedural imaging is required to successfully position the zenith flex aaa endovascular graft and assure accurate apposition to the aortic wall.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.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: aneurysm enlargement, aneurysm rupture and death, endoleak, endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion.6.5 endoleak management: ¿type lll endoleaks caused by graft defects, inadequate seal or disconnection of the modular components were treated with additional ballooning or prostheses.¿ 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 flex aaa endovascular graft.Additional considerations for patient selection include but are not limited to: patient's anatomical suitability for endovascular repair non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: with a length of at least 15 mm, with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18 mm, with an angle less than 60 degrees relative to the long axis of the aneurysm, and with an angle less than 45 degrees relative to the axis of the suprarenal aorta iliac artery distal fixation site greater than 10 mm in length and 7.5 to 20 mm in diameter (measured outer wall to outer wall) freedom from significant femoral/iliac artery occlusive disease that would impede flow through the endovascular graft.The final treatment decision is at the discretion of the physician and patient.8 patient counseling information patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Physicians should refer patients to the patient guide regarding risks occurring during or after implantation of the device.Procedure-related risks include cardiac, pulmonary, neurologic, bowel and bleeding complications.Device related risks include occlusion, endoleak, aneurysm enlargement, fracture, potential for reintervention and open surgical conversion, rupture, and death 10.5 device sizing guidelines.The choice of diameter should be determined from the outer wall to outer wall vessel diameter and not the lumen diameter.Undersizing or oversizing may result in incomplete sealing or compromised flow.11 directions for use anatomical requirements.Proximal aortic neck lengths should be a minimum of 15 mm with a diameter measured outer wall to outer wall of 18 ¿ 32 mm.Pre-implant determinants verify from pre-implant planning that the correct device has been selected.Determinants include: 1.Femoral artery selection for introduction of the main body system (i.E., define respective contralateral and ipsilateral iliac arteries).2.Angulation of aortic neck, aneurysm, and iliac arteries.3.Quality of the aortic neck.4.Diameters of infrarenal aortic neck and distal iliac arteries.5.Distance from renal arteries to the aortic bifurcation.6.Length from the aortic bifurcation to the internal iliac arteries/attachment site(s).7.Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable graft/artery interface site.8.Consider the degree of vascular calcification.12.4 ultrasound: ultrasound imaging may be performed in place of contrast ct when patient factors preclude the use of image contrast media.Ultrasound may be paired with non-contrast ct.A complete aortic duplex is to be videotaped for maximum aneurysm diameter, endoleaks, stent patency and stenosis.Included on the videotape should be the following information as outlined below: transverse and longitudinal imaging should be obtained from the level of the proximal aorta demonstrating mesenteric and renal arteries to the iliac bifurcations to determine if endoleaks are present utilizing color flow and color power angiography (if accessible).Spectral analysis confirmation should be performed for any suspected endoleaks.Transverse and longitudinal imaging of the maximum aneurysm should be obtained.Evidence provided by the complaint facility, device history record, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.Based on the information provided and the results of the investigation, a definitive cause could not be established.However, endoleak is a known inherent risk of the device per the ifu.The appropriate internal personnel have been notified.Per the 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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