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

Model Number	ENBF2816C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	10/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant devices are: enlw1616c93e , s/n: (b)(4); use by date: (b)(6) 2013; upn # (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 abdominal aortic aneurysm on.It was reported that the patient presented emergently in the emergency room approximately 5.5 years post index procedure with a ruptured aneurysm.The patient was taken to the or where it was observed that the ipsilateral limb and the extension limb that was used to extend it in the initial procedure had separated causing a type iii endoleak.The physician used other manufacturer¿s devices to bridge the separation and the event was resolved.Per the physician the cause of the event cannot be determined.No additional clinical sequelae were reported, and the patient is fine.

• 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: 7056720
• Report Number: 2953200-2017-01851
• Device Sequence Number: 944313
• Product Code: MIH
• UDI-Device Identifier: 00613994762481
• UDI-Public: 00613994762481
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 11/23/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2014
• Device Model Number: ENBF2816C166E
• Device Catalogue Number: ENBF2816C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/23/2017
• 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: 71 YR