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	G55245
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: branch graft: zbis-12-61-58 (lot a894160); zenith aaa main body: tffb-26-82-zt (lot 4685604); iliac leg graft (same side as branch-left): zsle-16-56-zt (lot 4817831); atrium icast 85408 (lot 20524549).(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
The user facility reported the patient from a study; in which there was left common iliac aneurysm growth requiring interventional surgery/removal.On (b)(6) 2014, the patient received a branch graft, mainbody, two iliac leg grafts and another manufacturer's device.No other procedures were performed at the time of the index procedure.The patient was discharged from the hospital on (b)(6) 2014.Follow-up imaging has been reviewed by core lab at 1 month, 6 months, 12 months, and 3 years.On (b)(6) 2014, the patient underwent thrombolysis of the zbis graft due to thrombosis.The devices remain intact and patent with no evidence of kinks, endoleaks, or migration.On the 3-year computerized tomography (ct) scan, core lab identified growth of the right common iliac artery and stated that the distal right iliac limb graft was not fully apposed to the wall.Per core lab: "no stent migration.There is aneurysmal degeneration of right common iliac artery." on (b)(6) 2017, the patient underwent a right external to internal iliac artery bypass and placement of two of another manufacturer's stents in the right common and external iliac arteries.The patient was discharged from the hospital on (b)(6) 2017.
Event or Problem Description
No additional information has been reported since the submission of the initial mdr.
Additional Manufacturer Narrative
Evaluation investigation: the actual complaint device was not returned.Imaging was provided for review.A review of the provided imaging, device history records, instructions for use, and quality control data was conducted.A pre-implantation computerized tomographic angiography (cta) and angiography was provided.Implantation angiography was also provided.Post implantation ctas at two, six, twelve and thirty-six months were provided.Secondary intervention angiography at two months was also provided.Impressions of the imaging reviewer: a new aneurysm developing at the edge of the right zsle sealing stent is confirmed.The aneurysm growth beginning at six months and continuing through 36 months extended under the right zsle-24-56-zt sealing stent and threatened to engulf it in the future.The original presence of a small thrombosed or atheromatous filled aneurysm projection adjacent the new aneurysm indicated that the new aneurysm developed de novo from an intrinsically diseased cia wall or from the interaction of diseased un-excluded cia wall with the sealing stent edge.The imaging reviewer suggests that an intrinsic diseased cia wall or the interaction of the disease un-excluded cia wall with the sealing stent edge is the source of the aneurysm.The aneurysm between the 12th and 26th month expanded well beyond the sealing stent design diameter from 26mm to 31mm.The device history records were reviewed and no non-conformances were noted.Each zenith device is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure, specifically the correct graft placement location.The ifu also advises on appropriate patient follow-up so that changes in the structure, should they occur, can be identified and addressed before causing clinical problems.This complaint focuses on the right cia aneurysm growth that was treated with bypass three years post initial procedure.Pre-implantation, implantation and post implantation (two, six, twelve and thirty-six months) images were provided.Based on the image review conducted on these images, aneurysm dilation of the right cia at the distal right zsle sealing stent margin developed between six and 12 months, continuing through 36 months.A small stable thrombus or atheromatous filled aneurysm projection at the edge of the new aneurysmal dilation had been stable since implantation, its presence indicated intrinsic disease of the cia at the sealing stent edge.Based on the event description it is evident that the patient did not have a two-year follow-up procedure.Per the ifu, all patients should be advised that endovascular treatment requires life-long, regular follow-up to access their health and the performance of their endovascular graft.Patients with specific clinical findings (eg., endoleaks, enlarging aneurysm or changes in the structure or position of the endovascular graft) should receive enhanced follow-up.The complaint is confirmed based on the image review.The qc specification and design history files were reviewed and no evidence was found that the device is manufactured out of specification and no non-conformances were noted in the manufacturing department.Based on the image review findings, the potential cause for the right cia aneurysm is procedure related, patient condition related to occurrence.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.The appropriate cook 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.

• 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: 7400022
• Report Number: 1820334-2018-00976
• Device Sequence Number: 1470219
• Product Code: MIH
• UDI-Device Identifier: 10827002552453
• UDI-Public: (01)10827002552453(17)170301(10)4870100
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G55245
• Device Catalogue Number: ZSLE-24-56-ZT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 07/12/2018
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 87