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

Model Number VNMF3434C174TU

Device Problem Leak/Splash (1354)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Pain (1994); Numbness (2415); Vascular Dissection (3160)

Event Date 05/22/2021

Event Type  Death  

Event Description

Valiant navion stent grafts were implanted for the endovascular treatment of a 52mm thoracic aneurysm.It was reported approximately 15 months post the index procedure the patient presented emergently in critical condition complaining of chest pain, mid back pain, high bp and numbness and tingling in the lower extremities.A ct on (b)(6) 2021 showed growth in the aortic diameter (60mm)) and interval development of an acute type b dissection of the thoracic aneurysm from the distal stent edge.The new aortic dissection involved the distal descending thoracic aorta, originating distal to the level of the pre-existing endograft with an increase in size of distal thoracic and proximal abdominal aortic aneurysm at level of dissection from 54mm to 56mm.A type ib endoleak which appeared localized to the distal end of the graft within the descending thoracic aorta was also observed.Critical treatment was provided and the patient discharged, however the patient expired on (b)(6) 2021.  per the physician the cause of the enlargement, dissection and endoleak are undetermined.The cause of death was due to the dissection of the thoracic aortic aneurysm.No additional clinical sequelae were reported and the patient is expired.

Manufacturer Narrative

Other relevant device(s) are: product id: vnmc4646c175tu, serial/lot #: (b)(4) ubd: 15-oct-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.

Manufacturer Narrative

B5; additional information received : it was reported that the device that contained the dissection and type ib endoleak could not be determined.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
• Type of Device: 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: 14841445
• MDR Text Key: 294850658
• Report Number: 9612164-2022-02430
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00763000100643
• UDI-Public: 00763000100643
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Device Model Number: VNMF3434C174TU
• Device Catalogue Number: VNMF3434C174TU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 08/15/2022
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Female