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

Model Number	ETBF3216C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etlw1616c124e, serial/lot #: (b)(6), ubd: 19-jul-2015, udi#: (b)(4).Film evaluation summary: the reported type ia endoleak was likely confirmed on the films provided; however the cause of the event could not be conclusively determined.Complete post-implant cts were also not available for a more thorough assessment of the event.The pre-implant anatomy is unknown and earlier post implant cts were not available for comparison of the stent graft configuration in vivo overtime.Lack of total seal and apposition of the distal left limb was observed without evidence of type ib endoleak.It is possible that disease progression with aneurysm morphology changes overt the 10 years since implantation may have contributed to this event, but this could not be confirmed.Analysis of the available films did not review any obvious stent graft integrity issues.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
An endurant ii stent graft (etbf3216c166e) and endurant limb (etlw1616c124e) was implanted during the endovascular treatment of an a bdominal aortic aneurysm on (b)(6) 2013.It was reported on (b)(6) 2024, follow-up imaging identified a type ia endoleak.Per the physician the cause of the type ia endoleak is undetermined.No additional clinical sequelae were reported, and the patient will be monitored.

• 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: 19087533
• Report Number: 9612164-2024-01743
• Device Sequence Number: 20614979
• Product Code: MIH
• UDI-Device Identifier: 00613994990990
• UDI-Public: 00613994990990
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2015
• Device Model Number: ETBF3216C166E
• Device Catalogue Number: ETBF3216C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/11/2024
• Date Device Manufactured: 07/03/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 81 YR
• Patient Sex: Male