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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 (annex a) investigation ¿ evaluation (b)(6) hosptial informed cook on (b)(6) 2022 of an event with a 70-year-old male patient where physician could not seal the leg graft.The complaint device was a zenith flex with spiral-z technology aaa endovascular iliac leg (rpn: zsle-11-74-zt, lot: 14688453).The cook rep was called to the facility to assist a case.The rep picked up the devices at the warehouse and brought to the hospital that day.Once arriving at the facility, the patient was already on the table and the procedure was in progress.The rep was unsure how long the case had been going before he arrived.The rep was informed the patient had bilateral iliac aneurysms.The internal iliac artery (hypogastric) had been coiled off.The physician wanted to cover aneurysm with a graft from another manufacturer but was unable to use that device due to the patient's heparin allergy, so the physician wanted to use a cook device instead.It is unknown if the physician was aware of the patient's allergy prior to the start of the procedure.The physician initially told the rep that he needed an 11 graft.He then said to his colleague that he needed a 13 graft.Later, he said he needed a 15 or a 16 graft.The rep was not provided with any ct imaging to guide device selection; he was only shown fluoroscopy images taken during the case.The rep complied with the physician's request and gave him the initially requested 11 size graft.It should be noted a main body graft was not placed.The graft was flushed and deployed following the deployment steps outlined in the ifu with the exception that no main body or leg graft on the opposite side was used.The graft performed as expected.After the graft was deployed, post dilation was performed correctly despite using an incorrect balloon.The rep noted the facility did not have the correct supplies to do an evar procedure (i.E., incorrect balloon, no lunderquist wire).After graft deployment, sealing was not achieved (rpn: zsle-11-74-zt, lot: 14879623, mfg.Report reference #: (b)(4)) and a second zsle graft (zsle-11-74-zt product, lot 14688453) was placed, sealing was not achieved.The graft migrated up slightly past the hypogastric (internal iliac artery) and stayed there.Both grafts were undersized and exhibited endoleaks.It was noted that the aneurysm was still receiving blood fill.It was then discovered that measurements above and below the hypogastric measured 16.The rep informed the physician that they would need at least a 16 graft or potentially a 20 graft to achieve proper sealing.At the end of the case, the attending physician was aware that the grafts were not properly placed and acknowledged that the patient will need further intervention.The patient was discharged because they arrived at the facility as an outpatient.It was reported the patient had a heparin allergy.A consulting vascular surgeon has been in communication with the cook rep to discuss patient conversion to full evar.However, the patient's daughter is having reservations as she works for a sister hospital/facility and was not pleased with the current graft situation.It was noted that there is an ongoing investigation on the attending physician who performed the procedure, as he is an interventional cardiologist and may not have privileges to perform an evar procedure.Reviews of the documentation, including the complaint history, dhr, drawing, instructions 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, no physical examination could be conducted.However, medical imaging was provided by the facility for expert image review.Based on pre-op imaging, the implanted zsle iliac leg grafts were severely undersized to achieve proximal and distal seal at the intended landing zones.The proximal left cia diameter is 15 to 17 mm on the pre-op ct, while the implanted graft has a proximal diameter of only 13 mm (11 mm graft).A proximal extension zsle leg is placed after the first one fails to seal, but the implanted device is also an 11 mm graft (13 mm proximal diameter), so proximal seal is again not obtained.The implanted graft is also undersized to achieve distal seal.The distal landing zone (proximal left eia) is 15 mm in diameter, while the distal graft is only 11 mm.In addition to being undersized, the first zsle leg is also positioned too low, nearly in the proximal aneurysm segment, and not in the intended landing zone.The second zsle leg is placed for proximal extension to the intended landing zone.The zsle iliac leg graft is not indicated to be used alone for the treatment of iliac aneurysms.The ifu for the zsle iliac leg graft states: ¿the zenith spiral-z aaa iliac leg.Is indicated for use with the zenith aaa endovascular graft family of products.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.¿ additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that appropriate inspections are in place relative to the reported device failure.A review of the device history record (dhr) for lot 14688453 and related subassemblies found no nonconformances that could have contributed to the reported failure.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The device was packaged with ifu t_zaaasz_rev4.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.Suggested instructions for use: read all instructions carefully.Failure to properly follow the instructions, warnings and precautions may lead to serious surgical consequences or injury to the patient.1 device description: 1.1the zenith spiral-z aaa iliac leg.The zenith spiral-z aaa iliac should be used in conjunction with the zenith aaa main bodies (flex, fenestrated, low profile, alpha, universal distal body, and flex aui), branch, or renu and is a part of a modular system consisting of multiple components, most typically a bifurcated main body and two iliac legs (fig.1).The iliac legs are constructed of full-thickness woven polyester fabric sewn to two self-expanding stainless-steel cook-z stents and a continuous nitinol spiral stent with braided polyester and monofilament polypropylene suture.The graft is fully stented to provided stability and the expansile force necessary to open the lumen of the graft during deployment.Additionally, the cook-z stents placed at the ends of the graft provide the necessary attachment and seal of the graft to the vessel wall.3 contraindications: ¿ patients with known sensitivities or allergies to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, polytetrafluoroethylene (ptfe), or gold.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/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: ¿ 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.¿ for sizing requirements and a list of key anatomical elements that may affect successful aneurysm exclusion using a device 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 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 increase the risk of embolization.A vascular conduit technique may be necessary to achieve success in some patients.¿ successful patient selection requires specific imaging and accurate measurements; please see section 4.3, pre-procedural measurement techniques, and imaging.4.3 pre-procedure measurement techniques and imaging: ¿ clinical experience indicates that contrast-enhanced spiral computed tomographic angiography (cta) with 3-d reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy prior to treatment with the zenith spiral-z aaa iliac leg.If contrast-enhanced spiral cta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.Lengths: ¿ all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.¿ after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is required, including: 1) abdominal radiographs to examine device integrity (separation between components or stent fracture) and 2) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity, and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information.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 spiral-z aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries.¿ fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.¿ avoid damaging the graft or disturbing graft positioning after placement in the event re-instrumentation (secondary intervention) of the graft is necessary.¿ verify that the appropriate iliac leg is selected for insertion on the contralateral side of the patient before implantation.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.¿ claudication (e.G., buttock, lower limb).¿ endoleak.¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; and corrosion.¿ surgical conversion to open repair.7 patient selection and treatment: 7.1 individualization of treatment.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).¿ patient¿s suitability for open surgical repair.¿ patient¿s anatomical suitability for endovascular repair.¿ patient¿s ability to tolerate general, regional, or local anesthesia.¿ 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 16 french vascular introducer sheath.¿ 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).8 patient counseling information: ¿ all patients should be advised that endovascular treatment required life-long, 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 enhanced follow-up.Specific follow-up guidelines are described in section 12, imaging guidelines and postoperative follow-up.¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told the regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.At a minimum, annual imaging and adherence to routine postoperative follow-up requirements is required and should be considered a life-long commitment to the patient¿s health and well-being.¿ 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.Aneurysm rupture may be asymptomatic, but usually presents as: pain; numbness; weakness in the legs; any back, chest abdominal or groin pain; dizziness; fainting; rapid heartbeat or sudden weakness.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 (see section 5.1, observed adverse events and section 5.2, potential adverse events).The physician should complete the patient i.D.Card and give it to the patient so that he/she 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).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.¿ patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be told the regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.¿ physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstance of each individual patient.The minimum requirement for patient follow-up (described in the instructions for use for the zenith aaa device that was used) should be maintained even in the absence of clinical symptoms (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.¿ duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak, patency, tortuosity, and progressive disease.In this circumstance, a non-contrast ct should be performed to use in conjunction with the ultrasound.Ultrasound may be a less reliable and sensitive diagnostic method compared to ct.After review of the ifu, cook has concluded the device labeling contains appropriate warnings, precautions and instructions to the user related to the reported failure.Evidence provided by the complaint facility, device failure analysis, dhr, complaint history, manufacturing documents, and verification testing, suggests that the device was manufactured to specification.There is no evidence of nonconforming devices in house or in the field.Based on the information provided, expert review of medical imaging provided by the facility, and the results of our investigation, it is likely that the medical procedure contributed to the event.The leg is part of a 3-modular system that includes one main body and two leg grafts intended to be implanted together per the instructions for use (ifu).The image review states, ¿the zsle iliac leg graft is not indicated to be used alone for the treatment of iliac aneurysms.The ifu for the zsle iliac leg graft states: ¿the zenith spiral-z aaa iliac leg.Is indicated for use with the zenith aaa endovascular graft family of products.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.¿ in addition, the reviewer states, ¿based on preop imaging, the implanted zsle iliac leg grafts are severely undersized to achieve proximal and distal seal at the intended landing zones.¿ 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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