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

Model Number	ENBF2516C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant stent graft system was implanted in patient for endovascular treatment of an abdominal aortic aneurysm.It was reported that approximately seven years after the index procedure , the patient presented emergently.The patient acquired infection from urethral catherization.As a result, the stent graft was infected.The patient received treatment.The stent graft system was explanted and an open tube graft was implanted.The event was resolved.Per the physician, the cause of the events could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Other relevant device is: catalogue # enlw1616c124e, serial (b)(4), use by date: 2013-07-06, manufacture date: 2011-07-11, (b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT 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: 6799800
• Report Number: 2953200-2017-01304
• Device Sequence Number: 831985
• Product Code: MIH
• UDI-Device Identifier: 00613994762221
• UDI-Public: 00613994762221
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 07/23/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2013
• Device Model Number: ENBF2516C166E
• Device Catalogue Number: ENBF2516C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2017
• Supplement Date Received by Manufacturer: 07/23/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 09/14/2017
• 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: 72 YR