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	Thrombus (2101)
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 in initially reported on 14mar2019 that during patient¿s first follow up, the zisl leg and zsle leg are partly occluded.There is a lot of thromboses in both legs.Additional information was provided on 18mar2019.The patient underwent a standard endovascular aneurysm repair (evar) in (b)(6) 2019.A follow up ct shows a lot of thrombosis in the legs.At the time of this report no additional procedures have been performed.Additional patient and event details have been requested; however, at the time of this report no additional information has been received.This report references the occlusion in the zsle leg.
Event or Problem Description
On (b)(6) 2019, informed the patient gender is male not female as previously reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information/correction: the investigation is in progress.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation/evaluation the complaint device was not returned for evaluation as it remains implanted in the patient.Imaging was provided for review.A document based investigation has been performed including a review of the provided imaging, device history record, instructions for use, and quality control data.The patient has a history of hypertension, hypercholesterolemia and aortocoronary bypass (acb) operation.There are no medical records to review.If the patient had an acb, it is likely that the patient¿s cardiac output would be compromised or an arrhythmia could develop and place patient at risk for thrombosis.We are not aware of the patient¿s medication regimen.In addition, hypercholesterolemia and hypertension contribute to atherosclerosis causing damage to the vessel endothelium and narrowing of the arteries.This endothelial damage causes turbulent flow and thereby contributing to increased coagulation and thrombus formation.Stills of angiographic and fluoroscopic imaging were provided.These images were reviewed by product management, who concluded the following: based on those limited images it appears there is significant thrombus within the right zisl and a lining of thrombus on the medial portion of the left zsle.The overlap of both seems to be within the instructions for use (ifu) based on image 001.Image 002 makes the angulation at the aortic bifurcation look much worse than image 001.This sharp take off and change in direction can contribute to flow disturbance and limb occlusion.It is difficult to appreciate everything based on these images alone.A review of the device history records (dhr) for the final assembly and graft subassembly records revealed no non-conformances.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 educed blood flow through the graft limb and/ or leaks may be required to undergo secondary interventions or surgical procedures.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 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.There are adequate instructions and warnings to facilitate proper placement and use of the device.The complaint is confirmed based on the limited imaging available.The thrombus formation in the left zsle was found 3 months post-implantation.From the imaging, it appears as if there is sharp angulation at the bifurcation.Sharp angulation can present challenges to patency of the arteries, and as the blood flow through the lumen slows down, there is an increased chance of clotting.Cook concludes that this incident is related to patient anatomy.There is no evidence to suggest the device was not manufactured to specifications, and there is no evidence to suggest that the device was placed incorrectly in the patient.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.Cook will continue to monitor for similar complaints.The appropriate personnel have been notified of this event.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.
Event or Problem Description
Patient has pain in the left leg when walking more than 200m.After the last ct the patient was put on warfarin in addition to asa that the patient was already on.On the preoperative pictures there is some calcification, but not significant.Some tortuosity in the common and external iliac arteries.The lot number 8679588 was provided for the main body device used in this patient.
Additional Manufacturer Narrative
Additional information provided on 12apr2019.D10: zimb-32-108 and zisl-24-77.The investigation is in progress.A follow up report will be submitted should additional relevant information become available or upon completion of the investigation.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.

• 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: 8470900
• Report Number: 1820334-2019-00761
• Device Sequence Number: 19240956
• Product Code: MIH
• UDI-Device Identifier: 10827002552460
• UDI-Public: (01)10827002552460(17)210319(10)8652734
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2019

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: 03/19/2021
• Device Model Number: N/A
• Device Catalogue Number: ZSLE-24-74-ZT
• Device Lot Number: 8652734
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/12/2019; 04/26/2019; 05/31/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/26/2019; 05/23/2019; 05/31/2019
• 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: Other