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	G55230
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Claudication (2550); No Code Available (3191)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: g38612 - zbis-10-45-41 - right side, lot a979149, zalb-26-84 - left side insertion, lot 7236354, zsle-16-56-zt - right side insertion, lot 6985413, zsle-9-90-zt - left side insertion, lot 7158790.(b)(4).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 patient underwent an endovascular aneurysm repair (evar) on (b)(6) 2016.The physician has reported, the left iliac zsle limb has occluded and he was going to perform a fem-fem crossover graft to address the problem.No patient symptoms were reported.Additional information has been requested regarding the secondary intervention and patient outcome.There were two occluded limbs reported on this patient.This report is related to manufacturer report # 1820334-2018-03472.
Additional Manufacturer Narrative
Additional information received on 17dec2018: (b)(4).
Event or Problem Description
Additional information received on 17dec2018: it was reported that the patient has recovered well.His only complaint is slight buttock claudication.The patient was on aspirin for anti-coagulation therapy.
Additional Manufacturer Narrative
Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use, quality control, as well as a visual inspection of the device was conducted during the investigation.The device is still implanted in the patient, therefore was not returned for evaluation.However, a postoperative ct study was provided for the investigation.Thrombus occlusion of both the left zsle-9-90 and the left zsle-13-39 grafts were confirmed with the imaging provided.There was no indication that the device was manufactured out of specifications.A contributing factor for the thrombus formation was severe 93-degree angulation of the mid left zsle legs.The image reviewer did not report a device kink or lumen narrowing in this segment.A mural thrombus was observed within the main body zalb-26-84 (lot 7236354), in which another complaint was registered.Additionally, a document-based investigation evaluation was performed.It was concluded that there are sufficient inspection activities in place to identify this failure mode prior to device distribution.Design testing showed that the affected product is safe and effective for its intended use.A review of the device history record found no nonconformances in lot 5878572 that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number.Because there are no related nonconformances and adequate inspection activities have been established, it was concluded that there is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported 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." the image review confirmed thrombus occlusion of both the left zsle-9-90 and left zsle-13-39 grafts.A mural thrombus was also observed in the zalb-26-84 graft that is connected to the left leg occlusion.A contributing factor identified for the thrombus occlusion was severe 93-degree angulation within the mid left zsle segment.Although a device kink or significant lumen narrowing were not observed, the angulation could have increased the risk for thrombus formation resulting from higher shear forces of blood flow through this region.Although patient anatomy was a contributing factor identified from the imaging provided, a definitive cause for the complete occlusion of both zsle graft 2 years post implantation could not be established in this investigation.The appropriate 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
No new event description information to report at this time.

• 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: 8166899
• Report Number: 1820334-2018-03473
• Device Sequence Number: 2024828
• Product Code: MIH
• UDI-Device Identifier: 10827002552309
• UDI-Public: (01)10827002552309(17)180609(10)5878572
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: 06/09/2018
• Device Model Number: G55230
• Device Catalogue Number: ZSLE-13-39-ZT
• Device Lot Number: 5878572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 12/17/2018; 05/31/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/16/2019; 06/26/2019
• 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