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

Model Number	VNMC4040C175TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Valiant navion stent grafts were implanted as part of a dissect-n study for the treatment of a chronic type b aortic dissection with degenerative thoracoabdominal aortic aneurysm.It was reported from a corelab review of a ct with and without contrast carried out approximately 13 months post implant that there was a presence of aortic enlargement distal to the endograft +27.4mm.There is increasing caliber of thoracic aorta along distal aspect of endograft within the upper abdominal aorta.The maximal measure is 81mm, previously 53mm.There was no endoleaks, migration or false lumen perfusion noted.Approximately 9 months later the patient underwent open repair as treatment for the known aortic enlargement.During the procedure , the patient underwent left femoral cutdown with side grafting to the left common femoral artery, extent iii thoracoabdominal aortic aneurysm repair using 28 mm non medtronic graft via left femoro-femoral partial cardiopulmonary bypass was performed also.This resolved the event.The patients post-operative course was unremarkable.The site assessed the event as not related to device or procedure but having a causal definite relationship to the dissection under study.The medical monitor assessed it as related to the study device, not related to the study procedure and related to the dissection under study.
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: vnmc4646c95tu, serial/lot #: (b)(4), ubd: 12-aug-2022, 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
B5; additional information received: the cec assessed the event as related to the study device, not related to the study procedure.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: 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: 15605060
• Report Number: 9612164-2022-03794
• Device Sequence Number: 19367267
• Product Code: MIH
• UDI-Device Identifier: 00763000260897
• UDI-Public: 00763000260897
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: VNMC4040C175TU
• Device Catalogue Number: VNMC4040C175TU
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 06/19/2024
• Date Device Manufactured: 09/22/2020
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: Black Or African American