MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II EXTENSION CUFF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETEW2020C82E
Medical Device Problem Codes	Defective Component (2292); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant etew2020c82e lilac extension was implanted in the endovascular treatment of a ulcer.It was confirmed the device was pre pped and opened in the standard fashion.Percutaneous access was established and the device was loaded on the wire and advanced to access site bareback.The device would not enter the artery and was stuck at the access site.The device was removed and a 16fr sheath was used to deliver and deploy the stent graft.The cause of the difficulty inserting the device was found to be a 3-5mm gap between the tapered tip and graft cover which caused a lip which led to the device getting stuck at the access site.
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.
Additional Manufacturer Narrative
Film evaluation summary: the reported positioning difficulties and gap between the delivery system tip and graft cover could not be confirmed from the limited still images available, therefore, the cause of the events could not be determined.Complete pre-implant cts were not available for review and the provided images did not depict the access vessels.Procedural angiograms showing the advancement attempts were also not available for assessment of the reported events.Device photo evaluation summary: one (1) image received from the account confirmed deformation to the graft cover tip material which is raised and partially bunched.A gap is visible between the taper tip nose cone and the graft cover tip.The reported positioning difficulties leading to deformation in-vivo are confirmed through image review.B5; additional information received: it was reported that the patient had a pre-operative rupture attributed to an ulcerated plaque.The patient had no known history of ulcers.The access vessel was clear and had 9-10mm in diameter.There was no damage noted to the device's box and it was sealed.The gap between the tip and graft cover was noticed after the device was removed from the patient after failed insertion.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 EXTENSION CUFF
• 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: 21399971
• Report Number: 9612164-2025-00824
• Device Sequence Number: 12815674
• Product Code: MIH
• UDI-Device Identifier: 00613994991393
• UDI-Public: 00613994991393
• 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,Followup
• Report Date (Section B): 03/12/2025

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 Model Number: ETEW2020C82E
• Device Catalogue Number: ETEW2020C82E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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: 85 YR
• Patient Sex: Male
• Patient Weight: 66 KG