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	05/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: etlw1624c82e sn (b)(4), expiration date: 2016-05-15, udi # (b)(4).
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 the patient presented emergently with a ruptured aneurysm with a type ii endoleak form a lumbar artery, type ia endoleak due to disease progression and type ib endoleak on the right limb.The decision was made to explant the stent graft and open repair.The physician stated that the cause of the event was because the patient was lost to follow-up and from the type ii endoleak.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 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: 6661178
• Report Number: 2953200-2017-01026
• Device Sequence Number: 10809772
• Product Code: MIH
• UDI-Device Identifier: 00613994991348
• UDI-Public: 00613994991348
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2017

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: 05/20/2016
• Device Model Number: ETLW1628C124E
• Device Catalogue Number: ETLW1628C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 74 YR