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The patient was participating in study protocol 16-16.He was an 88-year-old male at the time of the event.The primary indication for the study procedure was an aortic aneurysm.Pre-procedural imaging completed 13 days pre-procedure showed all vessels patent.Prior to the study device deployment, a superior mesenteric artery (sma) stent and left renal artery stent were implanted.The patient underwent endovascular aortic repair (evar) on (b)(6) 2020.The procedure was done percutaneously via right and left femoral artery access sites.The following cook devices were placed during the procedure: zenith tx2 dissection endovascular graft straight component (rpn: zdeg-pt-32-82-pf, lot number e3956367) zenith flex with z-trak aaa endovascular graft main body extension (rpn: esbe-32-58-zt, lot number 13021009) non-cook devices placed during the procedure included: vascular graft, peripheral graft, balloon expandable covered stent, 9x38x80, balloon expandable covered stent, 7x75 graft, 7x32 stent, 9x38 stent.During the index procedure, it was reported that the zdeg-pt-32-82-pf (lot# e3956367) was implanted without difficulty ¿within the coeliac.¿ the degree of oversizing was 20%.No balloon was used during the procedure.It was reported that the graft fabric did not cover the left subclavian artery.The procedural angiogram showed no endoleak.The device was patent without any separation or device integrity issues.There was no evidence of branch vessel obstruction at the completion of the procedure.On (b)(6) 2020 (two days post-procedure), a computed tomography (ct) scan was completed.All vessels that were assessed were patent.No endoleak was present.The study device was patent.No device integrity issues, separation of the device, or evidence of migration had been reported.On (b)(6) 2020 (13 days post-procedure), a ct revealed a type 1a proximal endoleak.It was reported that the devices involved in the type 1a endoleak were the zenith tx2 dissection endovascular graft straight component (rpn: zdeg-pt-32-82-pf, lot number e3956367) and the zenith flex with z-trak aaa endovascular graft main body extension (rpn: esbe-32-58-zt, lot number 13021009).It was also noted that there was a type ii endoleak present.The study device was patent and there were no device integrity issues, migration, or separation of devices.On (b)(6) 2020 it was reported the patient experienced a deterioration of general condition.The patient¿s treatment included change of medication (details unknown) and palliative treatment the patient died on (b)(6) 2020.The patient exited the study at the time of death.Additional information has been requested but is not available at the time of this report.No information has been provided indicating that the zenith flex with z-trak aaa endovascular graft main body extension (rpn: esbe-32-58-zt, lot number 13021009) caused or contributed to the patient¿s death.The subject of this report is the type 1a endoleak on the zenith flex with z-trak aaa endovascular graft main body extension (rpn: esbe-32-58-zt, lot number 13021009) that was identified on (b)(6) 2020.
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.Hospital (b)(6) informed cook on (b)(6) 2023 of an incident involving a zenith flex with z-trak aaa endovascular graft main body extension (rpn: esbe-32-58-zt, lot: 13021009).On (b)(6) 2020, the 88-year-old male patient had a procedure completed in which a zdeg-pt-32-82-pf (lot e3956367) was implanted without difficulty.The patient also had an esbe 32-58-zt bridging stent implanted.On (b)(6) 2020 (13 days post procedure), a ct revealed a type ia proximal endoleak.It is stated the devices involved were the zenith extension esbe 32-58-zt and zdeg-p-32-82.It was also noted that there was a type ii endoleak present.The study device was patent and there was no device integrity issues, migration or separation of devices.On (b)(6) 2020, it was reported the patient experienced a deterioration of general condition.Treatment included a change of medication and palliative treatment which resulted in the patient¿s death on 09nov2020.Clarification with the site indicated deterioration of general condition linked to the multi-comorbidities present in the patient.The patient had pre-existing medical conditions including a history of myelodysplastic syndrome, type ii diabetes, stage 3 chronic kidney disease, hypertension, asa class 3 (a patient with severe systemic disease).Reviews of the documentation, including the complaint history, device history record, drawing, instruction for use (ifu), manufacturing instructions, quality control procedures and specifications of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are sufficient inspection activities in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot 13021009 and related subassembly lots found no nonconformances that could have contributed to the reported failure.It should be noted that no other complaints have been associated with the final lot number.Cook also reviewed product labeling.The product ifu, t_eaaaz_rev1 ¿zenith aaa ancillary components with the z-trak introduction system¿ provides the following information to the user related to the reported failure mode: for the zenith product line there are five applicable suggested instructions for use (ifu).This ifu describes the suggested instructions for use for the zenith aaa endovascular graft ancillary components (main body extension, iliac leg, iliac leg extension, converter, and iliac plug).For information on other zenith components, please refer to the following suggested instructions for use.1 device description: 1.1 zenith aaa ancillary components.Zenith aaa ancillary components include main body extensions, iliac legs, iliac leg extensions, converters and iliac plugs.These components are constructed from the same materials as the principal graft modules.All expanding stainless steel cook-z stents with braided polyester and monofilament polypropylene suture.The modules are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment.Additionally, the cook-z stents provide the necessary attachment and seal of the graft to the vessel wall.The aortic main body extensions, iliac legs and iliac leg extensions can be used to provide additional length to their respective portions of the endovascular graft.The converters and iliac plugs can be used to convert a bifurcated graft into an aorto-uniiliac graft, if necessary (e.G., cases of type iii endoleak, limb occlusion or unattainable contralateral limb cannulation.2 indications for use.The zenith aaa ancillary components with the z-trak introduction system are indicated for use with the zenith aaa graft during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.4 warnings and precautions: 4.1 general.Additional endovascular interventions or conversion to standard open surgical repair following endovascular repair should be considered for patents 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.The zenith aaa ancillary components have not been evaluated for use with grafts other than zenith aaa stent grafts.4.2 patient selection, treatment and follow-up.The zenith aaa main body extension is designed to treat aortic neck diameters no smaller than 18 mm and no larger than 32 mm.The zenith aaa main body extension 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 10mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall) is required.Theses sizing measurements are critical to the performances of the endovascular repair.Adequate iliac or femoral access is required to introduce the device into the vasculature.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 distal fixation site (<10 mm); 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 fixation and sealing of the implantation sites.Necks exhibiting these key anatomic elements may be more conducive to graft migration.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 the profile of a 14 french to 20 french vascular introducer sheath.Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the ancillary components and/or may increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.4.4 device selection: strict adherence to the zenith aaa endovascular graft ancillary components ifu sizing guide is strongly recommended when selecting the appropriate device size (tables 10.5.1 through 10.5.6).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 aaa ancillary components 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: aneurysm enlargement.Aneurysm rupture and death.Aortic damage, including perforation, dissection, bleeding, rupture and death.Death.Endoleak.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 aaa ancillary components.Additional considerations for patient selection include, but are not limited to: co-morbidities (e.G., cardiac, pulmonary or renal insufficiency prior to surgery, morbid obesity).Patient¿s anatomical suitability for endovascular repair.Iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 14 french to 20 french vascular introducer sheath.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.Physicians should refer the patient 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.The physician should complete the patient i.D.Card and give it to the patient so that he/she can carry it with him/her at all times.The patient should refer to the card anytime he/she visits additional health practitioners, particularly for any additional diagnostic procedures (e.G., mri).11.2 main body extensions: main body extensions are used for extending the proximal body of an in situ endovascular graft.Evidence provided by the complaint facility, dhr, complaint history, and manufacturing documents 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, no returned product, and the results of our investigation, a definitive cause of the failure could not be established.Endoleak is a known inherent risk of the device per the ifu.The appropriate personnel have been notified.Per the 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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