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

Model Number	ESBF2814C103E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information received: it was reported that it is unclear if the leak is confined to the main body bifurcated device.It is also unclear which implanted devices are associated with the endoleak.This is a system report.The section d information is for the primary device, which was in use with the following: endurant ii aortic stent graft, product id: etcf2828c49e, serial number: (b)(6) endurant ii iliac stent graft, product id: etlw1616c93e, serial number: (b)(6) endurant ii iliac stent graft, product id: etlw1613c124e, serial number: (b)(6) endurant ii iliac stent graft, product id: etlw1613c93e, serial number: (b)(6) endurant ii iliac stent graft, product id: etlw1613c82e, serial number: (b)(6) endurant ii iliac stent graft, product id: etlw1613c124e, serial number: (b)(6).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 analysis: the reported endoleak was confirmed on the films provided; however the cause and subtype of endoleak could not conclusively be determined.Lack of pre-implant did not allow for assessment of the pre-implant anatomy and earlier post implant cts were not available for assessment of the stent graft configuration over time.Endoleak interrogation via selective angiograms (i.E., injection of contrast from several levels within the stent graft) to determine the endoleak type was not available for review, and the imaging quality was suboptimal due to artifacts.A type ia endoleak seems unlikely as there appeared to be an adequate proximal seal.Type ii can be ruled out as no patent collateral vessels were noted at the level of the aneurysm sac.A type iiia separation endoleak is not considered a potential cause as adequate overlap between stent graft components was observed.While a type iiib fabric endoleak, due to the presence of calcification which may have interacted with the stent grafts, cannot be ruled out, it is likely that a type ib endoleak may be present due to the observed loss of distal seal of the right iliac limb.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
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 stent graft system was implanted during the endovascular procedure of an aaa it was reported that a follow-up ct taken four years later showed a possible endoleak.Per the physician the cause of the event is undetermined.No additional clinical sequelae were provided and the patient will be monitored.

• Brand Name: ENDURANT IIS 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: 21190322
• Report Number: 9612164-2025-00345
• Device Sequence Number: 8640043
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• 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: 2020
• 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): 02/24/2025

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 Expiration Date: 04/07/2022
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 01/20/2025; 01/31/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 01/21/2025; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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: 80 YR
• Patient Sex: Female