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	G55238
Medical Device Problem Codes	Complete Blockage (1094); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Ischemia (1942); No Code Available (3191)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: lunderquist wire guide.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 a (b)(6)-year male patient underwent an evar procedure which the zenith flex with spiral-z technology aaa endovascular graft iliac leg, g55238, was used.Patient has a total occlusion of the right ipsilateral limb.Patient developed acute limb ischemia and required a fem-fem crossover surgical intervention.Patient was symptomatic and required emergent surgery due to occlusion.The patient was taking asa as anticoagulation/antiplatelet medication.There was not pre-existing thrombus in the right iliac and there was minimal calcification in the vessels containing the grafts.There was no stenosis present in the vessel prior to device placement and no evidence of a graft kink in the ipsilateral zsle-16-74-zt.The patient reportedly did well post fem-fem crossover.
Event or Problem Description
No new information has been received.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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.Two pre-implantation ctas, pre and post bladder cancer surgery including lymph node dissection were provided.Implantation angiography was also provided.The bladder wall was diffusely thickened consistent with bladder carcinoma and radiation change.Bilateral iliac, retroperitoneal and inter-aortocaval lymphadenopathy indicated either stage iiib or stage iva bladder cancer.The 60mm abdominal aortic aneurysm was stable.The iliac arteries were severely tortuous, particularly the right external iliac artery (eia).The right iliac tortuosity index was 1.5 (195mm/130mm) and the left 1.41 (198mm/140mm).A tortuosity index greater than 1.2 is severe.A 98 mm long likely 28mm diameter zimb was implanted from the right and two 74mm long zsles implanted as iliac legs.Although the legs were free of stenosis and tortuosity post implantation, the right eia remained severely tortuous.Impressions of the imaging reviewer: zsle occlusion cannot be confirmed as imaging of the complaint event was not provided.The complaint report indicates that the occlusion occurred the same day as the implantation.No procedural related eia injury was observed although complete post implantation eia angiography of the eias was not provided.Severe iliac tortuosity increased the risk of procedural injury and or post procedural stenosis.Bladder cancer increases the risk of thrombotic events (bladder cancer, vol.4, no.2, pp.139-147, 2018).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 a review of the device history record (dhr) was performed for final assembly lot 9041726 and graft subassembly lot sa8377291.The review of both lots revealed zero non-conformances documented.This complaint could not be confirmed based on review of the imaging provided; however, severe iliac tortuosity and bladder cancer were revealed as contributing factors.There was no evidence that the device was manufactured out of specifications from the imaging provided.Graft occlusion is most often a result of thrombus formation, graft kinking and/or vessel stenosis.Since only pre-implantation cta and angiography from the implantation procedure were provided, the cause for zsle-16-74 graft occlusion post procedure cannot be determined.A contributing factor for graft kinking and vessel stenosis include severe tortuosity of the right eia (external iliac artery).A contributing factor for thrombus formation within the graft was the patient's pre-existing condition of bladder cancer.This may indicate that the patient was in a hypercoagulable state.Additional information provided on 06nov2018 stated that the patient had minimal calcification within the vessels containing the grafts and there was no stenosis in the vessels prior to device placement.Although there was no pre-existing stenosis reported, the image reviewer stated that severe iliac tortuosity increased the risk of procedural injury and or post procedure stenosis.Additional information provided also included that there was no evidence of a graft kink in the ipsilateral zsle-16-74-zt.The image reviewer also stated that the leg grafts were free of stenosis and tortuosity post implantation.This gives no evidence that the occlusion was caused by graft kinking.The ifu provided with the device warns, 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).Re-intervention (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.Based on the information and imaging provided for this investigation, the cause for the reported occlusion was most likely thrombus formation within the zsle-16-74 graft.A contributing factor for thrombus formation within the graft is that the patient was likely in a hypercoagulable state due to the pre-existing condition of bladder cancer.The ifu provided with the device warns that patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specifications.A definitive cause for the graft occlusion could not be established.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.

• 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: 8108735
• Report Number: 1820334-2018-03405
• Device Sequence Number: 2027196
• Product Code: MIH
• UDI-Device Identifier: 10827002552385
• UDI-Public: (01)10827002552385(17)210803(10)9041726
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: 08/03/2021
• Device Model Number: G55238
• Device Catalogue Number: ZSLE-16-74-ZT
• Device Lot Number: 9041726
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 02/25/2019
• 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: 76 YR