MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT NAVION; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	VNMC3131C90TU
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Ischemia (1942); Insufficient Information (4580)
Date of Event	02/07/2020
Type of Reportable Event	Death
Event or Problem Description
Valiant navion stent grafts were implanted during the endovascular treatment of a thoracic aortic aneurysm.Additionally, 7 endurant stent grafts were also implanted during the procedure.The valiant navion stents (b)(6) and (b)(6) were implanted in the thoracic aorta, with the second device overlapping at proximal end of the first to ensure a more secure seal.Endo-debranching using an endurant stent graft in the proximal abdominal aorta was a modified endurant unitary graft; it was extended into each of the celiac, sma, l <(>&<)> r renal arteries and lined with non mdt self-expanding stents; it was extended into distal abdominal aorta with 16x20x124 endurant iis stent grafts x2 (with the second overlapping at the proximal end of the first for better seal/coverage) it was reported during the index procedure a type iv endoleak (unknown which device) was detected.Following the index procedure, a follow up ct scan revealed an unknown endoleak in the thoracic aorta, along the right posterolateral margin of the valiant navion graft.The endoleak was observed at the site where the components overlapped at the diaphragmatic hiatus.Post the procedure, cta for concern for mesenteric ischemia ¿demonstrated evidence of low flow through visceral limbs of graft due to external compression due to anatomical tortuosity.This resulted in sma thrombosis along with l leg arterial insufficiency.Due to these findings the patient was emergently taken to the operating room for angioplasty and stenting of the mesenteric and renal limbs of the unitary graft along with lytic therapy of the sma graft.¿ post-operation a lack of neurological response prompted a head ct revealing l mca stroke, operative intervention was unfeasible and the patient expired.Per the physician the cause of the endoleaks is undetermined.The cause of death was due to complications with the unitary stent graft.Following the procedure the patient suffered a left sided mca territory stroke in the context of complications of abdominal aortic stent grafting causing poor visceral vessel blood flow.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v nmc3131c90tu, serial/lot #: (b)(6), ubd: 25-nov-2021, udi#: (b)(4).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corelab review of ct imaging from the reported event did not observe an endoleak, stent ring enlargement or stent ring migration.The imaging was not evaluable for fracture.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALIANT NAVION
• 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: 17884891
• Report Number: 9612164-2023-04518
• Device Sequence Number: 6938777
• Product Code: MIH
• UDI-Device Identifier: 00763000100971
• UDI-Public: 00763000100971
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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: 05/14/2021
• Device Model Number: VNMC3131C90TU
• Device Catalogue Number: VNMC3131C90TU
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/24/2023
• Date Device Manufactured: 05/15/2019
• 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 H10...."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 63 KG