MAUDE Adverse Event Report: COOK INC ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G55242
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423); Device Endoleak (4074)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Clinical Endoleak (4843)
Date of Event	09/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Cook was notified of a type ib endoleak on a zenith flex with spiral-z technology aaa endovascular graft iliac leg.The discovery was made in an imaging review.The patient underwent an endovascular aortic repair (evar) procedure on an unknown date.The patient presented to the hospital on (b)(6) 2024 with abdominal pain.A computed tomography (ct) scan was completed.The ct showed a type 1a endoleak on the zenith low profile aaa endovascular graft main body.The uncovered supra renal fixation had detached from the graft sealing stent.The graft migrated distally contributing to the loss of the proximal seal and resulting in enlargement of the aneurysm sac.Reintervention was planned and the physician inquired about the placement of a cuff to address the endoleak on the zenith low profile aaa endovascular graft main body.However, details regarding the reintervention have not been provided at the time of this report.Imaging from the event was reviewed.The image review identified a type 1b endoleak on the right, ipsilateral zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt).Additionally, mild partial thrombus was present at the limb junction of the ipsilateral (right) proximal zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt).The focus of this report is the type 1b endoleak and mild partial thrombus in the right ipsilateral proximal zenith flex with spiral-z technology aaa endovascular graft iliac leg.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): postal code: (b)(6).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.
Additional Manufacturer Narrative
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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Investigation-evaluation: cook was notified of a type ib endoleak and mild partial thrombosis on a zenith flex with spiral-z technology aaa endovascular graft iliac leg.The discovery was made in an imaging review.The male patient underwent an endovascular aortic repair (evar) procedure on an unknown date.The patient presented to the hospital on (b)(6) 2024 with abdominal pain.A computed tomography (ct) scan was completed.The ct showed a type 1a endoleak on the zenith low profile aaa endovascular graft main body.The uncovered supra renal fixation had detached from the graft sealing stent.The graft migrated distally contributing to the loss of the proximal seal and resulting in enlargement of the aneurysm sac.Reintervention was planned and the physician inquired about the placement of a cuff to address the endoleak on the zenith low profile aaa endovascular graft main body.However, details regarding the reintervention have not been provided at the time of this report.Imaging from the event was reviewed.The image review identified a type 1b endoleak on the right, ipsilateral zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt).Additionally, mild partial thrombus was present at the limb junction of the ipsilateral (right) proximal zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-20-74-zt).The focus of this report is the type 1b endoleak and mild partial thrombus in the right ipsilateral proximal zenith flex with spiral-z technology aaa endovascular graft iliac leg.Reviews of documentation including the complaint history, drawing, device history record (dhr), quality control, specifications, manufacturing instructions (mi), and instructions for use (ifu) of the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.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 dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.It should be noted that this device is supplied via a one-device lot.A complaint history search did not identify any other events for this lot for a related failure mode.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure modes: 4 warnings and precautions 4.1 general ¿ read all instructions carefully.Failure to properly follow the instructions, warnings and precautions may lead to serious consequences or injury to the patient.¿ 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 ¿ 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.4.3 pre-procedure measurement techniques and imaging 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.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.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.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; component separation from another graft component; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perifgraft flow; and corrosion.8 patient counseling information ¿ all patents should be advised that endovascular treatment requires life-long, regular follow-up assess their health and the performance of their endovascular graft.Patents 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 1.Final angiogram position angiographic catheter just above the level of the renal arteries.Perform angiography to verify that the renal arteries are patent and that there are no endoleaks.Verify patency of internal iliac arteries.2.Confirm there are no endoleaks or kins and verify position of proximal gold radiopaque markers.Remove the sheaths, wires and catheters.Note: if endoleaks or other problems are observed, refer to the suggested instructions for use for the zenith aaa endovascular graft ancillary components 7.1 individualization of treatment the risks and benefits should be carefully considered for each patient before use of the zenith spiral-z aaa iliac leg.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 ¿ the risk of aneurysm rupture compared to the risk of treatment with zenith spiral-z aaa iliac leg ¿ 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 7.5-20mm 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 ¿ all patents should be advised that endovascular treatment requires life-long, regular follow-up assess their health and the performance of their endovascular graft.Patents 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 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 ¿ physicians should evaluate patients on an individual bases and prescribe follow-up relative to the needs and circumstances 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., 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.Imaging was provided for this event and was reviewed by a physician.The impression from the reviewer¿s report indicated "1.An infrarenal aaa was previously repaired using a zalb-20-74 main body graft, an ipsilateral zsle-20-74 leg on the right, and a contralateral zsle-20-74 and additional extension zsle on the left.Based on measurements, the extension leg is likely a zsle-16/20-90 graft.2.At 8+ years postop, there is complete separation of the suprarenal stent from the zalb graft with distal migration of the graft 22 mm from the lra and fixation stent.There is loss of proximal graft wall apposition with a limited rim of contrast around the proximal graft, but this does not extend into the aaa sac.3.The proximal neck dilates significantly from 27 x 28 mm at the lra to 37 x 38 mm at 15 mm below the lra.It is unclear whether the graft separation and migration resulted in the disease progression, or if there was disease progression with loss of graft wall apposition resulting in component separation from shearing forces.Also, preoperative imaging is not provided to confirm adequate proximal neck anatomy at the time of repair.4.A limited endoleak is seen within the aaa sac but this does not communicate with a clear source.It does not appear to be a type 1a endoleak.There is foreign material artifact in the posterior sac that could represent glue or coil embolization of a type 2 endoleak.The contrast pool in the sac could be retained contrast if this intervention was performed very recently.5.There is aneurysmal dilation of the right cia with loss of circumferential graft wall apposition of the distal right zsle leg.Contrast is seen around the distal leg graft but does not extend proximally into the aaa sac.This is likely due to disease progression but preop imaging is not provided to confirm adequate anatomy at the time of repair." based on the information provided, no product returned, and the results of the investigation a definitive root cause for the type 1b endoleak could not be established.However, it is possible disease progression was a contributing factor, but preoperative imaging would be needed to confirm.Additionally, a definitive root cause of the thrombus formation was not able to be established.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 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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• Common Device Name: 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: 21446970
• Report Number: 1820334-2025-00171
• Device Sequence Number: 12747621
• Product Code: MIH
• UDI-Device Identifier: 10827002552422
• UDI-Public: (01)10827002552422(17)180609(30)1(10)5921234
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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: 06/09/2018
• Device Model Number: G55242
• Device Catalogue Number: ZSLE-20-74-ZT
• Device Lot Number: 5921234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 04/09/2025; Not provided
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 04/10/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2015
• 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: COOK RPN: ZALB-30-128 LOT 4424161.; COOK RPN: ZSLE-20-74-ZT, LOT 5366985.; COOK ZSLE (UNKNOWN IF 16/20 DIAMETER, LENGTH 90MM).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male