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

Model Number	ETBF3216C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); No Code Available (3191)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: etlw1616c93e, serial/lot #: (b)(4), ubd: (b)(6) 2015, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(4), ubd: (b)(6) 2015, udi#: (b)(4); product id: etlw1616c82e, serial/lot #: (b)(4), ubd: (b)(6) 2015, udi#: (b)(4).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 a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported that the patient presented emergently approx.4 years post index procedure with a rupture at the proximal aspect of the endurant ii bifurcated stent graft and the right renal artery.The patient received intervention with the addition of an endurant cuff and 5 endoanchors.The event was reported to have been resolved.Per the physician, the cause of the event cannot be determined.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: 7713316
• Report Number: 2953200-2018-01095
• Device Sequence Number: 16410437
• Product Code: MIH
• UDI-Device Identifier: 00613994990983
• UDI-Public: 00613994990983
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2015
• Device Model Number: ETBF3216C145E
• Device Catalogue Number: ETBF3216C145E
• Device Lot Number: V04083489
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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