MAUDE Adverse Event Report: COVIDIEN LLC ENDURANT II STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number	UNK-CV-SR-ENDUR-II
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Rupture (2208); Obstruction/Occlusion (2422)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature was reviewed regarding ¿ expanding the evar pool with non-ifu patients: how important is subjective physician assessment?¿.The time frame of this study was over a five-year period.A total of 248 patients underwent evar with a cohort of the study population outside the stent grafts instructions for use (ifu).Endurant ii and non-mdt stent grafts were implanted in the patient population.The following adverse events occurred: occlusion, blood loss, fistula, rupture, perforation, intervention no further information was provided pertaining to medtronic products.
Additional Manufacturer Narrative
Medtronic received the following information from a journal article entitled; ¿expanding the evar pool with non-ifu patients: how important is subjective physician assessment?¿.Iner h, yurekli i, karaagac e, peker i, tunca nu, tellioglu tm, durmaz h, selcuk ho, yilik l journal of clinical medicine.2025; 14(4):1237.Https://doi.Org/10.3390/jcm14041237 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 STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22077863
• Report Number: 1282497-2025-00348
• Device Sequence Number: 15312264
• Product Code: MIH
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: UNK-CV-SR-ENDUR-II
• Device Catalogue Number: UNK-CV-SR-ENDUR-II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male