|
Investigation ¿ evaluation it was reported that a zenith flex aaa endovascular graft bifurcated main body fractured.The patient had the graft placed during an endovascular aneurysm repair (evar) on (b)(6) 2013.The ultrasound and x-ray images were normal, and no issues were noted during the follow-up of 2022.During the 2023 follow-up, there was no increase in the aneurysm sac size per ultrasound imaging.However, the x-ray imaging showed the suprarenal fixation and the suprarenal ring had both fractured off of the graft.Upon this finding, a computed tomography (ct) scan has been requested.No additional information has been provided by the customer.This report captures the suprarenal ring fracture off of the graft.Another report under manufacturer reference #1820334-2023-01768 captures the suprarenal fixation fracture off of the graft.Reviews of the complaint history, device history record (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; therefore, no physical examinations could be performed.Medical imaging was requested but none provided for review.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that appropriate inspections are in place relative to the reported device failure.Cook also reviewed the device history record (dhr) for the final product lot and the subassembly work orders, and zero nonconformances have been reported.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaaf_rev4.The ifu includes the following, warnings, precautions, and instructions for proper placement of the device.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.4.2 patient selection, treatment and follow-up ¿ 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 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.¿ successful patient selection requires specific imaging and accurate measurements; please see section 4.3 pre-procedure 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 flex aaa endovascular graft.If contrast-enhanced spiral cta with 3-d reconstruction is not available, the patient should be referred to a facility with these capabilities.Lengths ¿ the long-term performance of endovascular grafts has not yet been established.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, stent fracture or barb separation) 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 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 ¿ do not continue advancing any portion of the delivery system if resistance is felt during advancement of the wire guide or delivery system.Stop and assess the cause of resistance; vessel, catheter or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis or in calcified or tortuous vessels.¿ repositioning the stent graft distally after partial deployment of the covered proximal stent may result in damage to the stent graft and/or vessel injury.¿ 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.¿ 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.¿ 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.¿ before deployment of the suprarenal stent, verify that the position of the access wire guide extends just distal to the aortic arch.5.2 potential adverse events ¿ aneurysm enlargement ¿ aneurysm rupture and death ¿ claudication (e.G., buttock, lower limb) ¿ endoleak ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; perigraft flow; barb separation and corrosion ¿ surgical conversion to open repair 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 ¿ ability to tolerate general, regional, or local anesthesia.¿ iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories of the delivery profile of a 16 french to 22 french vascular introducer sheath.¿ 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) 8 patient counseling information ¿ the long-term performance of endovascular grafts has not yet been established.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 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.¿ 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 that 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 are required and should be considered a lifelong commitment to the patient¿s health and well-being.¿ physicians must advise each patient 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; 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 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 directions for use ¿ iliofemoral access vessel size and morphology (minimal thrombus, calcium and/or tortuosity) should be compatible with vascular access techniques and accessories.Arterial conduit techniques may be required.¿ proximal aortic neck lengths should be a minimum of 15 mm with a diameter measured outer wall to outer wall of 18-32 mm.¿ iliac artery distal fixation site should be greater than 10 mm in length and 7.5-20 mm in diameter (measured outer wall to outer wall).12 imaging guidelines and postoperative follow-up 12.1 general ¿ the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess their health and 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 that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of aaas.¿ physicians should evaluate patient on an individual basis and prescribe their follow-up relative to the needs and circumstances of each individual patient.The recommended imaging schedule is presented in table 12.1.1.This schedule was use in the pivotal trial and is recommended even in the absence of clinical symptoms (e.G., pain, numbness, weakness).Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the stent graft) should receive follow-up at more frequent intervals.¿ the combination of contrast and non-contrast ct imaging provides information on aneurysm diameter change, endoleak, patency, tortuosity, progressive disease, fixation length and other morphological changes.¿ 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 comparted to ct.Evidence provided by the complaint facility, complaint history, dhr, 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 limited information provided, no device return or image review, and the results of the investigation, cook could not determine a definitive cause for the reported failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.
|
