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

Catalog Number	ESBF2314C103E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis conclusion the reported endoleak was confirmed on the films provided; however, the exact type and cause of the endoleak could not be fully determined.A type ia or type ib endoleak is unlikely as the proximal and distal seals appeared to be adequate.A type iiia junctional endoleak also seems less likely as there appeared to be sufficient component overlap.Type ii endoleak can be observed in both the 3 day and one month ct¿s feeding the aneurysm sac but it is not able to be confirmed that these are the sole cause of the contrast leakage observed.Type iii fabric endoleaks are generally less likely to occur at the index procedure but the 3 day post operative images show considerable calcification, which could have contributed to fabric abrasion, making this a possibility.In addition, a type iv endoleak at the 3 days post implant ct¿s cannot be fully ruled out.This most likely would have self-resolved before the one month ct¿s leaving the type ii endoleak and potential type iiib still present in the one month post-implant imaging.In conclusion, there is considered to be potential contribution from type ii, iiib and iv endoleaks observed in the patients imaging.Angiograms (including endoleak interrogation) could allow for a more comprehensive determinations of the endoleak source/cause but these were not received.Analysis of the 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.
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of a 55mm aaa.The patient had presented with flank pain and was treated emergently.During the index procedure, upon completion angiography, there was an endoleak discovered of unknown origin.Multiple runs were completed to find the source of the leak.The endoleak was suspected to be either a type ii or type iv at the time of the procedure.A follow-up ct 3 days later still showed the endoleak.The patient was discharged.At the 30 day ct, the endoleak was still there and the physician believed it to be a type iiib endoleak at this stage.The patient declines any intervention.The cause of the type iiib endoleak is unknown.No additional clinical sequalae were provided and the patient will be monitored.

• Brand Name: ENDURANT IIS 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: 23541696
• Report Number: 9612164-2025-05607
• Device Sequence Number: 13205484
• Product Code: MIH
• UDI-Device Identifier: 00643169439993
• UDI-Public: (01)00643169439993(17)270103
• 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: 2025
• 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): 11/13/2025

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 Catalogue Number: ESBF2314C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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
• Patient Age: 77 YR
• Patient Sex: Male