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

Model Number	ETBF2313C166E
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: (b)(4), expiration date: 2015-06-25, (b)(4).
Event or Problem Description
An endurant stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported directly from the patient that the patient had presented with flu like symptoms, fever and shaking.After recurring relapses and physician appointments the patient was diagnosed with abdominal infection that is believed to be on the endurant stent graft but unknown cause.Per the physician, the cause of the infection is unknown.No clinical sequelae were reported and the physician will continue to monitor the patient.
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: 6635091
• Report Number: 2953200-2017-00961
• Device Sequence Number: 12248
• Product Code: MIH
• UDI-Device Identifier: 00613994991188
• UDI-Public: 00613994991188
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 05/01/2015
• Device Model Number: ETBF2313C166E
• Device Catalogue Number: ETBF2313C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/12/2017
• 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: Other
• Patient Age: 76 YR