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	G55237
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Claudication (2550); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the (b)(6) male patient underwent an endovascular aneurysm repair (evar) of the aorta performed on (b)(6) 2018.At 5-months post-evar, the patient has total right limb occlusion of the implanted zenith flex with spiral-z technology aaa endovascular graft iliac leg.Further reported, the whole length of the limb is occluded and the patient has developed claudication requiring surgical intervention.According to the reporter, the patient needs a surgical fem-fem crossover.Additional patient, event and interventional activities have been requested.Additional products implanted during the evar procedure: zimb-28-84, lot # 8440375; zsle-16-56-zt, lot # 7811133.New information was provided on 05sep2018.The fem-fem has been performed.The date of this surgical intervention was not provided; however, the date has been requested.
Event or Problem Description
Patient outcome provided by the physician on (b)(6) 2018.The patient required a fem-fem bypass due to critical limb ischemia with a ischemic neuropathy and a drop in abi.Patient is doing well now.
Additional Manufacturer Narrative
Additional information: event.
Event or Problem Description
Additional information received on (b)(6) 2018.The patient was on asa for antiplatelet and anticoagulation therapy.The patient had chronic back pain as a pre-existing condition.The physician stated that the patient is going to be reassessed (possibly on (b)(6) 2018) as he had claudication with resolved critical limb ischemia.
Additional Manufacturer Narrative
Investigation/evaluation the device was not available for evaluation.Without the complaint device, a physical investigation was not able to be completed.Imaging was provided.A document based investigation has been performed.A review of the provided imaging, device history record, instructions for use, and quality control data was conducted.A pre-implantation cta, implantation angiography, and follow up cta¿s at six weeks and five months were provided.Pre-implantation, the distal aortic lumen diameter was maximally limited to 17mm x 21.5mm over a 7mm length.This remained unchanged at six weeks and five months with a diameter of 17.5mm by 21mm.The right leg gate diameter was minimally 8.5mm x 10.5mm at this point.Just distal to this point, mural thrombus partially narrowed the lumen at six weeks.The entire right zsle was thrombosed by five months.The aortic adventitia through the aneurysmal segment was ill-defined, consistent with an inflammatory aneurysm.The right zsle's implanted length of 74mm was only 2mm less than its design length.A right inferior pole renal infarct was the result of endograft exclusion of an accessory lower pole right artery originating from the aneurysm neck.Outflow and inflow were not limited.Both the right internal and external iliac arteries were normal.Impressions of the imaging reviewer: right zsle thrombus at six weeks progressing to occlusion at five months confirmed.The distal aortic lumen diameter was borderline narrowed to a mean of 18.5mm over a 7mm long segment.Minimum lumen diameter of 8.5mm x10mm was still inside the ipsilateral gate and just upstream from the thrombus.The aneurysm was likely inflammatory.A right renal infarct was the result of endograft coverage of an accessory lower pole right renal artery originating from the aneurysm neck.The instructions for use (ifu) states the following in consideration of the reported failure mode: indications for use: the zenith spiral-z aaa iliac leg with the z-trak introduction system is indicated for use with the zenith aaa endovascular graft family of products, including the zenith flex aaa endovascular graft, zenith alpha abdominal endovascular graft, zenith low profile aaa endovascular graft, zenith renu ancillary graft, zenith fenestrated aaa endovascular graft, zenith universal distal body endovascular graft, zenith flex aui, or zenith branch iliac endovascular graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.Warnings and precautions: ¿ patients experiencing reduced blood flow through the graft limb and/ or leaks may be required to undergo secondary interventions or surgical procedures.¿ pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliac's) 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.Dilation 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.¿ follow-up imaging should be carefully reviewed for narrowing within the graft leg.Patient 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.¿ patient with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.¿ excessive overlap of 10 mm above the main body graft bifurcation may increase the risk of limb thrombosis.Directions for use: ¿ section 11.1.5: ipsilateral iliac leg placement and deployment - 2.Advance slowly until the ipsilateral iliac leg graft overlaps a minimum of one stent inside the ipsilateral limb of the main body.Potential adverse events: adverse events that may occur and/or require intervention include, but are not limited to: ¿ arterial or venous thrombosis and/or pseudoaneurysm ¿ claudication (e.G., buttock, lower limb) ¿ graft or native vessel occlusion a review of the device history record (dhr) revealed no nonconformances that would have caused or contributed to the reported failure mode.Implantation in an aortic stenosis contributed to this incident.From the imaging provided, the aortic lumen diameter was maximally limited to 17mm x 21.5mm over a 7mm length.This resulted in right leg lumen diameter reduction to a minimum of 8.5mm x 10.5mm within the ipsilateral gate at this point.The image reviewer reported that mural thrombus formation was observed just distal to this point at six weeks, progressing to entire right zsle occlusion by five months.The ifu provided with the device warns that pre-existing regions of stenosis/narrowing (less than approximately 20 mm id in the aorta or 7 to 8 mm id in the iliac's) 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.Dilation 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.This complaint is confirmed based on imaging provided.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specifications.Therefore, the conclusion is the cause cannot be traced to the device.The adverse event is related to patient condition.The thrombus formation was observed just distal to the region of aortic stenosis which narrowed the right zsle to a minimum diameter of 8.5mm.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a change is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and 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
There has been no new event information received since the last report was submitted.

• 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
• MDR Report Key: 7860692
• Report Number: 1820334-2018-02488
• Device Sequence Number: 1986941
• Product Code: MIH
• UDI-Device Identifier: 10827002552378
• UDI-Public: (01)10827002552378(17)200109(10)7547786
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/13/2019

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: 01/09/2020
• Device Model Number: G55237
• Device Catalogue Number: ZSLE-16-56-ZT
• Device Lot Number: 7547786
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 09/10/2018; 12/17/2018; 01/25/2019
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 09/21/2018; 01/16/2019; 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR