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

Model Number	ENBF3620C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: enew2020c82e, serial/lot #: (b)(4), ubd: 16-aug-2013, udi#: (b)(4); product id: enlw1620c124e, serial/lot #: (b)(4), ubd: 30-mar-2013, udi#: (b)(4).Month and year valid.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 69mm diameter abdominal aortic aneurysm.It was reported that a ct scan carried out approximately six years later revealed an unknown endoleak.An endurant cuff and two endurant limbs were inserted but the endoleak was visible above the graft but not visible when inside the graft.The physician elected to implant endoanchors and a non mdt stent graft however the endoleak has not resolved and the physician ended the procedure at this time.Per the physician the cause of the event was possibly due to disease progression.No additional clinical sequelae were reported and the patient will be monitored.

• 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: 8098470
• Report Number: 2953200-2018-01600
• Device Sequence Number: 13931610
• Product Code: MIH
• UDI-Device Identifier: 00613994762368
• UDI-Public: 00613994762368
• 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
• Report Date (Section B): 11/22/2018

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: 10/05/2013
• Device Model Number: ENBF3620C145E
• Device Catalogue Number: ENBF3620C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/22/2018
• 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: 86 YR