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 Codes	Abdominal Pain (1685); Insufficient Information (4580)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: e tlw1616c82e, serial/lot #: (b)(4), ubd: 24-may-2014, udi#: (b)(4).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 the endovascular treatment of a 80mm abdominal aortic aneurysm.It was reported approximately 10 years post the index procedure, the patient presented to the er with abdominal pain.Cta demonstrated a type iii endoleaks between the main body and ipsilateral limb. a 1616124 limb was bridged between the main body and the ipsilateral limb.Per physician, the cause of the type iiia endoleak is most likely due to morphology changes which lead to increased tortuosity and disease progression in both common iliacs.No additional clinical sequelae were reported 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: 14218519
• Report Number: 9612164-2022-01608
• Device Sequence Number: 4194657
• Product Code: MIH
• UDI-Device Identifier: 00613994991034
• UDI-Public: 00613994991034
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 04/27/2022

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: 05/08/2014
• 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: 04/25/2022
• Initial Report FDA Received Date: 04/27/2022
• Date Device Manufactured: 05/14/2012
• 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: 65 YR
• Patient Sex: Female