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

Model Number	ETLW1613C82E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device is: catalogue # etbf3616c145e, serial # (b)(4), use by date 2017-05-20, upn# (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a greater than 55 mm in diameter abdominal aortic aneurysm.It was reported that, approximately one year and seven months post index procedure, the patient presented emergently with abdominal and back pain.It was discovered that the endurant ii stent graft system had bilateral distal type i endoleaks.The physician elected to implant bilateral iliac limb extensions and implanted a proximal extension.The proximal extension was implanted as a proactive therapy to eliminate any undefined or non-identified proximal endoleaks.The event was resolved.Per the physician, the cause of the event was due to dilatation of the common iliac arteries from the disease state.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6816118
• Report Number: 2953200-2017-01322
• Device Sequence Number: 13493342
• Product Code: MIH
• UDI-Device Identifier: 00643169467699
• UDI-Public: 00643169467699
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2017

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: 03/02/2017
• Device Model Number: ETLW1613C82E
• Device Catalogue Number: ETLW1613C82E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/24/2017
• 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: 87 YR