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

Model Number	VNMF3731C173TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Renal Failure (2041); Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of concomitant medical product: information references the main component of the system.Other relevant device(s) are: product id: v nmc3131c90tu, serial/lot #: (b)(4), ubd: 18-dec-2020, 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.
Event or Problem Description
Valiant navion stent grafts were implanted in the endovascular treatment of a ruptured taa.Debranching was also performed.  it was reported during a cta approximately 46 months post implant,the patient was found to have an undetermined endoleak that extends from aortic hiatus to the aortic bifurcation.The size of the aneurysm is stable.  no cause was reported.  no additional clinical sequalae were provide and the patient will be monitored.
Additional Manufacturer Narrative
Continued from h9: 3005364322-02-19-2021-001-r 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.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
Additional information received : it was reported the patient had presented emergently under 1 year post the last ct , with anemia s econdary to acute blood loss.Admission diagnosis listed a diagnoses of a gi bleed.The patient was then found to have right renal artery pseudoaneurysms with active bleeding, and aki.The following day, the patient underwent ct of the chest/abdomen/pelvis.The ct found the ascending and upper- descending thoracic aorta were normal.The stent graft of the thoracic (&) abdominal aorta were partially visualized.Aneurysm enlargement noted at the level of diaphragmatic hiatus (6.6cm at most axial), and large amounts of contrast filling indicated a persistent, large endoleak.Subtype not specified or clear.Per imaging report "no blush of contrast extending directly from the aorta but the pointing of the aneurysm and draping of the aneurysmal along the spine is compatible with instability and impending rupture or intermittent bleeding.The patient underwent multiple transfusions, and following vascular consult, a interventional embolization of the right kidney.The patients hemoglobin stabilized.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
Valiant navion stent grafts were implanted in the endovascular treatment of a ruptured taa on the (b)(6) 2019.Debranching was also performed.  core lab review of ct imaging from approximately 22 months post index procedure observed no endoleak, fracture, stent ring enlargement or stent ring migration.Core lab review of ct imaging from approximately 46 months post index procedure observed no endoleak, stent ring enlargement or stent ring migration and was not evaluable for fracture.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: 16641730
• Report Number: 9612164-2023-01355
• Device Sequence Number: 5353441
• Product Code: MIH
• UDI-Device Identifier: 00763000100865
• UDI-Public: 00763000100865
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/27/2024

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: 10/15/2020
• Device Model Number: VNMF3731C173TU
• Device Catalogue Number: VNMF3731C173TU
• 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: 03/04/2023
• Supplement Date Received by Manufacturer: 09/13/2023; 06/18/2024; 05/28/2024
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 09/13/2023; 06/21/2024; 06/27/2024
• Date Device Manufactured: 10/16/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 88 KG