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	G55239
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422); Claudication (2550); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(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 had a right limb occlusion post endovascular aneurysm repair (evar).The zenith flex with spiral-z technology aaa endovascular graft iliac leg (right limb) was implanted during the evar procedure performed on (b)(6) 2016.The patient has developed pain and claudication.The ipsilateral limb is completely occluded.There were no post implantation or adjunctive procedures performed.The manufacturer has requested additional information on patient treatment and patient's outcome but have not received a response at this time.
Additional Manufacturer Narrative
Concomitant medical products: zalb-30-108 lot: 6137166; zsle-16-74 lot: 6883852; zsle-16-90 lot: 5821557.Patient code: no code available - surgical intervention required.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 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.Each zenith device is shipped with instructions for use (ifu), which states warnings, precautions and instructions for use.Warnings and precautions state that patients with poor outflow or a hypercoagulable state (e.G., cancer) may be at an increased risk of a thromboembolic event.The device history record was reviewed and no non-conformances related to the reported failure mode were noted.Impressions of the imaging reviewer: right zsle thrombosis with occlusion is confirmed.The extent and thickness of mainbody thrombus was greater than usual and may have been encouraged by thrombus filling the distal mainbody dead space.The dead space thrombus could not have been the primary cause.Otherwise, the left zsle which was much closer and surrounded by the dead space thrombus would have thrombosed instead.The right zsle thrombosis was without anatomic explanation.The zsle was widely patent, straight, and without inflow or outflow obstruction.A right renal infarct was present.A two-year post implantation computed tomography angiography (cta) was provided and reviewed.Right zsle thrombosis with occlusion is confirmed.There was dead space in the distal main body lumen created by bilateral zsle extension into the endograft lumen.Thrombus also lined the mainbody and the filled dead space.The mainbody mural thrombus was continuous with the right zsle thrombus.The inferior pole, right kidney was infarcted from sealing stent covering of an inferior accessory right renal origin.Based on the information provided and the image review a cause for thrombus in the right zsle 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.
Event or Problem Description
It was reported that the patient was on asa (aspirin).The patient did not have calcified or tortuous anatomy.To treat the occlusion the patient had thrombolysis and multiple covered stents implanted.After the secondary procedure, the vessel was opened up and remains open.

• 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: 7723718
• Report Number: 1820334-2018-01973
• Device Sequence Number: 11025557
• Product Code: MIH
• UDI-Device Identifier: 10827002552392
• UDI-Public: (01)10827002552392(17)180424(10)5821557
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2018

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: 04/24/2018
• Device Model Number: G55239
• Device Catalogue Number: ZSLE-16-90-ZT
• Device Lot Number: 5821557
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 11/27/2018
• 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; Required Intervention