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

Model Number	ETLW1613C93E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: (b)(4), expiration date: 2014-07-02, udi # (b)(4).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 5 cm in diameter abdominal aortic aneurysm.It was reported that the patient had fallen and hit their side and presented emergently to the hospital.Currently, the abdominal aortic aneurysm is 7 cm in diameter.A ct revealed bilateral distal type i endoleaks and the stent grafts appeared to have migrated proximally.The angiogram confirmed bilateral distal type i endoleaks.The physician decided to implant endurant iliac limbs bilaterally extending the iliac limbs into the common iliac arteries.The bilateral distal type i endoleaks were resolved.The physician stated that the cause of the bilateral distal type i endoleaks and limb migration were related to the patient¿s anatomy of continued disease progression of the common iliac arteries.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: 6555942
• Report Number: 2953200-2017-00762
• Device Sequence Number: 609387
• Product Code: MIH
• UDI-Device Identifier: 00613994991539
• UDI-Public: 00613994991539
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2017

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: 09/28/2014
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2017
• Supplement Date Received by Manufacturer: 04/16/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 86 YR