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

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phone: (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.
Event or Problem Description
A physician indicated that over the past few years she has had patients experience limb occlusions a year or two after implant.Patient specific information was provided.The patient received the following cook devices during an endovascular aortic repair (evar) pm (b)(6) 2016.Zenith low profile aaa endovascular graft main body (rpn: zalb-24-118, lot 6660543).Zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-74-zt, lot 6656102).(b)(6) zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn:zsle-13-56-zt, lot 6664308).The surgeon identified a limb occlusion in a zenith flex with spiral-z technology aaa endovascular graft iliac leg 1-2 years later.It is unknown which iliac leg graft occluded.The patient underwent a femoral to femoral crossover repair on (b)(6) 2021.The physician indicated that they are unwilling to answer any further requests for additional information related to this event.
Event or Problem Description
During imaging review on (b)(6) 2022, the occluded device was identified as the zenith flex with spiral-z technology aaa endovascular graft iliac leg (rpn: zsle-13-56-zt, lot 6664308) that was placed on the right, ipsilateral side.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, d1, d4: lot number, udi, rpn, d10 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
Investigation ¿ evaluation port macquarie base hospital informed cook of an incident involving a zenith flex with spiral-z technology aaa endovascular graft iliac leg (unknown rpn).The 60-year-old male patient has an initial evar (endovascular aneurysm repair) procedure completed on 07mar2016.The following devices were implanted (b)(6)(lot 6660543), (b)(6)(lot 6656102) and (b)(6)(lot 6664308).A limb occlusion was reported 1 to 2 years after the initial evar.On 28jun2021 a fem-fem crossover repair was completed.The rep advised it was unknown which device the limb occlusion occurred.The image review confirmed the ipsilateral right (b)(6)was fully occluded.Therefore, documentation pulled will pertain to the (b)(6) lot 6664308.Reviews of the documentation, including the complaint history, device history record, 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 examinations could be conducted.However, post-operative computed tomography (ct) dated 31aug2022 was provided for expert image review on 06oct2022.The overlap above the main body graft bifurcation with the ipsilateral leg graft was 13mm.The overlap above the main body graft bifurcation with the contralateral leg graft was 16mm.There was misalignment of the ipsilateral and contralateral leg graft by 3mm.The reviewer noted it appeared that just the sealing stent of the right zsle-13-56-zt was outside of the ipsilateral right limb of the zimb-24-118.Thrombus was noted in the distal segment of the zalb-24-118 main body.Thrombus is noted in the proximal segment of the contralateral left zsle-13-74-zt.The ipsilateral right zsle-13-56-zt appears fully occluded.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 prior to distribution.A review of the device history record (dhr) for lot 6664308, graft subassembly lot sa6541566 and sewn graft supplied by vendor approved sesia medical, lot 1564815.36 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling.The product ifu, t_zaaasz_rev3 ¿zenith spiral-z aaa iliac leg with the z-trak introduction system,¿ provides the following information to the user related to the reported failure mode: 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 aneurysms, 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 sire 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.¿ 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 access techniques and delivery systems of a 14 french to 16 french 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 be necessary to achieve success in some patients.¿ pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliacs) have been shown to increase the risk of a thromboembolic event (e.G., graft limb occlusion).The potential for this increased risk in these patients may preclude placement of an endovascular graft.Dilatation of these regions with a noncompliant balloon and/or stent placement may be necessary to help assure maintained graft patency and to reduce the risk of a thromboembolic event.Additionally, the completion angiogram (with stiff wire guides removed) should be reviewed carefully to determine if further treatment in these regions is necessary (e.G., adjunctive ballooning or stenting).Failure to remove the stiff wire guide prior to the angiogram could mask any limb kinking or narrowing that might occur when the wire guide is removed.¿ follow-up imaging should be carefully reviewed for narrowing within the leg graft.Patients with a graft leg lumen of less than approximately 5 mm id may be at increased risk of a thromboembolic event (e.G., graft limb occlusion).Reintervention (e.G., noncompliant ballooning or stenting in these regions) should be considered to help assure maintained graft patency and to reduce the risk of a thromboembolic event.¿ patients with poor outflow or a hypercoagulable state (e.G, cancer) may be at an increased risk of a thromboembolic event.¿ the zenith spiral-z aaa iliac leg with the z-trak introduction system is not recommended in patients who cannot tolerate contrast agents necessary for intraoperative and postoperative follow-up imaging.All patients should be monitored closely and checked periodically for a change in the condition of their disease and the integrity of the endoprosthesis.¿ inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia 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.4.5 implant procedure ¿ inaccurate placement and/or incomplete sealing of the zenith spiral-z endovascular aaa iliac leg within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the internal iliac arteries ¿ excessive overlap 10mm above the main body bifurcation may increase the risk of limb thrombosis.5.2 potential adverse events adverse events that may occur and/or require intervention include, but are not limited to: ¿ aortic damage, including perforation, dissection, bleeding, rupture and death ¿ arterial or venous thrombosis and/or pseudoaneurysm ¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; component separation from another graft component/ suture break; occlusion; infection; stent fracture; graft material wear; dilation; erosion; puncture; pergraft flow; and corrosion ¿ graft or native vessel occlusion ¿ renal complications and subsequent attendant problems (e.G., dehiscence, infection) ¿ vessel damage 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 in addition to the risks and benefits of an endovascular repair, the physician should assess the patient¿s commitment and compliance to postoperative follow-up as necessary to ensure continuing safe and effective results.Listed below are additional topics to discuss with the patient as to expectations after an endovascular repair: ¿ 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.¿ 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 is required and should be considered a life-long commitment to the patient¿s health and well-being.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.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 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 for the failure could not be established; however, a likely contributing factor would be the procedure itself.The reviewer noted the overlap above the main body bifurcation with the contralateral limb was 16 mm and the ipsilateral overlap was 13 mm.The ifu states ¿¿excessive overlap 10 mm above the main body bifurcation may increase the risk of limb thrombosis.¿ in addition to this per the clinical assessment the ipsilateral iliac leg graft used (zsle-13-56-zt) was 13 mm in diameter.The ipsilateral leg of the main body graft produced to specification would have been 11 mm.This would have decreased the lumen of the ipsilateral leg graft and may have caused a disturbance in flow due to the excessive iliac leg graft fabric within the lumen of the main body graft ipsilateral leg.The disturbance in flow most likely caused thrombus formation and eventually occlusion in the right iliac leg graft.The ifu also lists thrombus/occlusion as a known inherent risk of using the device.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.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
• 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: 15523203
• Report Number: 1820334-2022-01574
• Device Sequence Number: 14083460
• Product Code: MIH
• UDI-Device Identifier: 10827002552316
• UDI-Public: (01)10827002552316(17)190210(10)6664308
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2022

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 Model Number: N/A
• Device Catalogue Number: ZSLE-13-56-ZT
• Device Lot Number: 6664308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 10/06/2022; 12/06/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/10/2022; 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 GRAFT MAIN BODY (ZALB-24-118, LOT 6660543); COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG; ZALB-24-118, LOT 6660543; ZSLE-13-56-ZT, LOT 6656102
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male