MAUDE Adverse Event Report: COOK INC ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Address: (b)(6).Initial reporter occupation: vascular surgeon.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was reported the patient needed an additional graft after the placement of a zenith flex aaa endovascular graft bifurcated main body.The physician discovered a type 3 endoleak one month post operation during a follow-up computed tomography (ct) scan and ultrasound.The endoleak was found in the "crutch of the main body." the aneurysm sac appeared to be stable and had no increase in size.The grafts remained in situ and no unintended part of the device remained inside the body of the patient.The physician has asked cook planning service to plan an additional graft for relining.The patient was reported to be stable.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation.St.John of god¿berwick informed cook on30sep2022 of an event with a male patient with a type 3 endoleak one-month post-op.The complaint device was zenith flex aaa endovascular graft bifurcated main body rpn: tffb-30-82-zt (product lot 14795535).One month post operation, during the follow-up computed tomography (ct) and ultrasound, the physician discovered a type 3 endoleak in the bifurcation area of the main body.There were no difficulties during implantation of the grafts in the index procedure.It was reported that the patient had calcification in the infrarenal seal zone and visceral vessels.It was reported the patient is stable; the aneurysm sac was stable, and there was no increase in size.The grafts remained in situ and no unintended part of the device remained inside the body of the patient.The physician plans to perform an additional procedure in the future to reline the graft.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control procedures, specifications, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned for investigation; therefore, no physical examination could be conducted.However, medical imaging was provided by the customer for expert review.An infrarenal aaa was previously repaired using a zenith flex (tffb-30-82) main body graft and bilateral zisl iliac legs.At 3 weeks postop, there is an endoleak beginning at the proximal neck junction and extending down into the distal aaa sac.This is most likely a type 1a or a type 3b endoleak involving the proximal tffb graft at the angulated neck junction between the 2nd and 3rd stent segments.The significant tortuosity of the neck and calcification in the proximal neck could be causing incomplete circumferential graft wall apposition and lack of adequate seal despite adequate neck length.Alternatively, a graft defect might be the result of the significant angulation of the graft at this level.Angiography with provocative maneuvers would help delineate this.The tortuosity as it appears on this study is outside the ifu for this device, though preop imaging would be needed to confirm the neck anatomy prior to device implant.The endoleak does not appear to communicate with the tffb graft at or adjacent to the flow divider.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot 14795535 and related subassembly graft lot sa14619010, graft kit lot sa14349893, and graft lot 2237295.3 revealed no related non-conformances.Cook concludes that the complaint device was manufactured per specification.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The device was packaged with ifu t_zaaaf_rev5.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.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 loner 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) and2) 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 ¿ 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.¿ 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.5 adverse events 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; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion ¿ graft or native vessel occlusion ¿ surgical conversion to open repair 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 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 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; 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 cadiac, 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 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).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 patients 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 used 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 compared to ct.12.6 additional surveillance and treatment ¿ aneurysms with type iii endoleak 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.Based on the information and the results of the investigation, a definitive cause for the reported failure could not be established.Based on the provided evidence from the customer and the completed investigation, a definitive cause for the reported failure could not be established.While the cause in this case is not known, it is possible that patient anatomy may have contributed to this incident.The image reviewer noted the significant tortuosity of the neck and calcification in the proximal neck could be causing incomplete circumferential graft wall apposition and lack of adequate seal despite adequate neck length.Alternatively, a graft defect might be the result of the significant angulation of the graft at this level.The image reviewer indicates that angiography with provocative maneuvers would help delineate the type of endoleak seen in the imaging.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.
Event or Problem Description
Additional information received on 05oct2022.No difficulty noted during implantation of the grafts in the index procedure.

• Brand Name: ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15578876
• Report Number: 1820334-2022-01612
• Device Sequence Number: 20651075
• Product Code: MIH
• UDI-Device Identifier: 10827002484228
• UDI-Public: (01)10827002484228(17)240615(10)14795535
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2024
• Device Model Number: N/A
• Device Catalogue Number: TFFB-30-82-ZT
• Device Lot Number: 14795535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZISL-16-77, LOT 14269089 - LEFT.; ZISL-20-77, LOT 14626600 -RIGHT,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male