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

Catalog Number	ETBF2313C166E
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis three still images received for analysis.First image depicts the distal section of an endurant device in its tray and pouch.The distal pouch seal appears to be intact.Second image depicts the proximal section of an endurant device in its tray and pouch.No label is evident to the pouch.Third image depicts an endurant ship carton label.Labelling information matches that reported in the complaint file.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 etbf2313c166e was intended to be implanted.It was reported when the box was opened, the outer package with the stickers/labels was missing.It was noted the seal was not broken and the box had not been opened before.It was reported when the box was opened both clear labels were still attached.When it was taken out of the box, the outside label package was not on it and it was unsure if device sterility was intact.The device was not used and a new device was opened and used to complete the procedure.The cause is undetermined.No patient complications were reported.
Additional Manufacturer Narrative
Product analysis the device was received in a sealed pouch in an opened shelf carton.Deformation was evident to the shelf carton.No label was evident to the pouch; residue was evident to the pouch over the device handle.No loose label was evident inside the shelf carton.All pouch seals were intact on receipt of the device 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.

• 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: 24855419
• Report Number: 9612164-2026-01881
• Device Sequence Number: 21141971
• Product Code: MIH
• UDI-Device Identifier: 00613994991188
• UDI-Public: (01)00613994991188(17)270303
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/05/2026

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: ETBF2313C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/22/2026; 06/05/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/08/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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 Sex: Unknown