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

Model Number	ETLW1616C82E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Rupture (2208)
Date of Event	09/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1610c93e, serial/lot #: (b)(4), ubd: 16-jul-2015, udi#: (b)(4); product id: enew1010c82e, serial/lot #: (b)(4), ubd: 22-jan-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.A valiant captivia stent graft system was also implanted for the endovascular treatment of an unknown size thoracic aortic aneurysm approximately eight months later.It was reported via technical services by the patient's son that the patient¿s stent graft has ¿burst¿ and the patient had died four years three months post the implantation of the valiant captivia stent graft system.The caller reported that the physician was going to report the incident to the fda as a device failure.The caller has not spoken to the physician since the event occurred.No additional clinical sequelae were reported.
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: 8883333
• Report Number: 9612164-2019-03333
• Device Sequence Number: 19469923
• Product Code: MIH
• UDI-Device Identifier: 00613994991577
• UDI-Public: 00613994991577
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 05/27/2015
• Device Model Number: ETLW1616C82E
• Device Catalogue Number: ETLW1616C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: Death
• Patient Age: 71 YR