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

Model Number	ETBF2316C145E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Unspecified Infection (1930)
Date of Event	12/17/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: this is a system report.The section d information is for the primary device, which was in use with the following: product id: vnmc3131c90tu, serial/lot #: (b)(6), ubd: 18-dec-2020, udi#: (b)(4); product id: etbf3616c145e, serial/lot #: (b)(6), ubd: 30-jan-2021, udi#: (b)(4); product id: etlw1620c124e, serial/lot #: (b)(6), ubd: 16-dec-2020, udi#: (b)(4); product id: etlw1620c124e, serial/lot #: (b)(6), ubd: 13-dec-2020, udi#: (b)(4); product id: etlw1616c93e, serial/lot #: (b)(6) , ubd: 25-mar-2020, udi#: (b)(4).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
Valiant navion stent grafts (vnmf3731c173tu & vnmc3131c90tu) a physician modified branch graft and an endurant ii stent graft system were implanted during the endovascular treatment of a thoracoabdominal aneurysm.It was reported approximately 4 years post the index procedure, the patient presented emergently and was hospitalized for a streptococcus mitis bacteraemia infection, with possible focus of infection at the aortic endograft in the descending thoracic aorta.Due to the suspicion of graft infection, a three-phase white blood cell was completed which did not show any active inflammation in the graft area.Ultimately the patient was discharged 6 days later on ivab.Following another hospitalization approximately 5 years post the index procedure, the patient had a repeat wbc scan which showed subtle uptake around the graft.The patient was given a treatment plan to continue antibiotic treatment with the additional antibiotic added.The cause of the infection was likely associated with 5 endurant stent graft since nuclear medicine tagged wbc scan showed uptake in the descending thoracic aorta at the site of endurant graft.An endoleak was observed and also associated with the branched graft.It is difficult to confirm on ct scan, but the endoleak appears to be type iii endoleak between graft components.The patient declined explantation and reconstruction with cryo graft for graft infection.Shortly after discharge the patient passed away due to intracranial hemorrhage.

• 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: 19971056
• Report Number: 9612164-2024-03683
• Device Sequence Number: 8966621
• Product Code: MIH
• UDI-Device Identifier: 00613994991201
• UDI-Public: 00613994991201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2020
• Device Model Number: ETBF2316C145E
• Device Catalogue Number: ETBF2316C145E
• 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: 07/18/2024
• Initial Report FDA Received Date: 08/13/2024
• Date Device Manufactured: 01/09/2018
• 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...."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 88 KG