MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETBF2316C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: etlw1616c124e sn (b)(4), expiration date: 2016-11-25, udi # unknown.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm diameter abdominal aortic aneurysm.It was reported that the patient had a routine follow up scan.The patient had been followed for a persistent type ii endoleak.On the most recent scan the physician noticed a new endoleak that was thought to be a type i or iii endoleak.An aortagram was done.After review of the films it was decided that there was an endoleak either from the proximal attachment zone or the bifurcation of the stent graft.There was a noticeable endoleak but the origin of the endoleak could not be determined.The plan was to implant a cuff or aui device.There was about 1cm from the renals to the top of the original graft.The physician then decided to place an endurant aortic cuff followed by two endurant iliac cuffs lining the limbs of the previous stent grafts.The aortic cuff was ballooned followed by kissing balloons in the iliacs.Another aortagram was performed and the endoleak had been successfully resolved.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6675330
• Report Number: 2953200-2017-01050
• Device Sequence Number: 19325882
• Product Code: MIH
• UDI-Device Identifier: 00613994991218
• UDI-Public: 00613994991218
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2017

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: 03/05/2016
• Device Model Number: ETBF2316C166E
• Device Catalogue Number: ETBF2316C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 10/05/2017
• 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: 72 YR