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

Model Number	ENBF3616C145E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a system report.The section d information is for the primary device, which was in use with the following: product id: enlw1616c93e, serial/lot #: (b)(6), ubd: 10-feb-2013, udi#: (b)(4), 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that a patient was treated for an aneurysm using a endurant stent graft system.Approx.13 years, 4 months post index procedure a computed tomography conducted without contrast due to the patient's poor kidney function, revealed a type ib endoleak.The physician's findings were based on what appeared to be non-opposed limbs observed in the imaging.The healthcare professional identified anatomy and disease progression as the cause of the event.It was confirmed that there were no allegations or issues related to the two endurant cuffs implanted during the initial procedure.
Additional Manufacturer Narrative
Additional information received; intervention was performed.The case turned to diagnostic based on the angio findings, with no further steps taken and no additional interventions planned for this patient.A type 1b endoleak was not observed via angiogram because imaging began at the proximal aorta, where a type 1a endoleak was identified which led to the physicians decision to not intervene further.The aortic neck had dilitated up to the renal arteries, resulting in a loss of seal since original intervention.Angiographic imaging did not capture views of the limb components, so confirmation of limb-related issues was not possible prior to case this was able to be confirmed via ct scan taken without contrast.Physician thought it was a possibility based on the ct, which is why we checked it first.Under fluoroscopy, both cuffs, the main body, and the limb were observed and confirmed no allegations against the cuffs.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.
Additional Manufacturer Narrative
Film evaluation summary: the reported type ia endoleak /possible ib endoleak were not confirmed on the films provided , therefore a cause of these events can not be provided.The films were non-contrast; therefore, the measurements were approximate, and no assessment of any endoleak or stent graft/vessel patency could be performed.The resolution of the images was also poor.The anatomy at implant is unknown, earlier post-implant films were not provided for comparison.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause, but these were not provided.It is possible that disease progression and aneurysm morphology changes, over the 13 year period of implantation were factors in the events but this could not be assessed.Analysis of the limited returned ct¿s did not reveal any out of specification 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.

• 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 ; 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: 20890670
• Report Number: 9612164-2024-05877
• Device Sequence Number: 8773545
• Product Code: MIH
• UDI-Device Identifier: 00613994762382
• UDI-Public: 00613994762382
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2025

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: 06/02/2013
• Device Model Number: ENBF3616C145E
• Device Catalogue Number: ENBF3616C145E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 01/27/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/20/2024; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2011
• 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...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male