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

Model Number	ETBF3616C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted during an endovascular procedure for the repair of a 100mm abdominal aortic aneurysm.It was reported that the patient presented emergently over 5 years later with back pain.It was discovered the patient had a type ia endoleak.The limb had a non-mdt balloon expandable stent that had pulled out of the endurant limb.The physician then extended the limb and to gain seal placed a cuff to resolve the type ia endoleak.As per the physician the cause of the event was due to anatomy as the aorta grew and elongated.No additional clinical sequalae was provided and the patient is fine.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12967723
• Report Number: 9612164-2021-04787
• Device Sequence Number: 17249196
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021

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: 12/06/2017
• Device Model Number: ETBF3616C145E
• Device Catalogue Number: ETBF3616C145E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2021
• Initial Report FDA Received Date: 12/09/2021
• Date Device Manufactured: 12/07/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male