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

Model Number	ETLW1628C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that a ct revealed a ruptured left common iliac artery.The iliac limb measure 33mm and the 28mm limb placed was no longer apposed to the aortic wall and there was a distal type i endoleak present.The left hypogastric artery was embolized and a 16x10x156 limb was placed in the existing 16x28x124 limb and extended into the left common iliac artery.It was noted that the right limb (16x10x93) was patent and had good seal.The event was reportedly resolved.The physician stated that the cause of the event was due to patient anatomy; specifically, aneurysmal disease progression of the left hypogastric artery.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• 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: 6404692
• Report Number: 2953200-2017-00396
• Device Sequence Number: 10881383
• Product Code: MIH
• UDI-Device Identifier: 00613994991348
• UDI-Public: 00613994991348
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2017

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: 06/19/2014
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2017
• Supplement Date Received by Manufacturer: 02/19/2017
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 09/30/2017
• 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: Life Threatening; Required Intervention
• Patient Age: 89 YR