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

Model Number	ENBF2513C166E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/25/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: enlw1613c124e, sn (b)(4), expiration date: 2014-03-02, udi # (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.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 a fusiform abdominal aortic aneurysm.It was reported that the patient expired of an unknown cause.The physician investigator assessed the death to not be related to the device or the procedure.No additional clinical sequelae were reported.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.The patient experienced a recent left proximal humerus fracture after a mechanical fall with course complicated by c.Diff colitis, acute kidney injury, lower extremity edema, and new onset of atrial fibrilation.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the patient was in hospice care at the time of death after experiencing several falls, fractured shoulder, uti's, c.Diff colitis, atrial fibrilation, renal failure, and heart failure all within the 4.5 months prior to death.The cause of death was determined to be due to congestive heart failure and renal failure.
Additional Manufacturer Narrative
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: 6578561
• Report Number: 2953200-2017-00814
• Device Sequence Number: 749234
• Product Code: MIH
• UDI-Device Identifier: 00613994762252
• UDI-Public: 00613994762252
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2017

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: 02/23/2014
• Device Model Number: ENBF2513C166E
• Device Catalogue Number: ENBF2513C166E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/27/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 06/09/2017; 06/28/2017; 10/03/2017
• 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: Death
• Patient Age: 87 YR
• Patient Weight: 56