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

Model Number VNMC3125C207TJ

Device Problem Material Deformation (2976)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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 Description

Valiant navion stent grafts were implanted during the endovascular treatment of a thoracic aneurysm. 2 debranching brachiocephalic non mdt chimney stents were placed during the tevar at the navion for ascending artificial blood vessel replacement.  follow-up was performed without any endoleaks.It was reported on an unknown date, due to a suspected infection intervention was performed.During the intervention blood was confirmed during abscess drainage so an endoleak was suspected.A thoracotomy was performed.Upon opening it, a small hole in the proximal side of (vnmc3731c207) was visually confirmed.Only the hole was sutured because there was adhesion in the front and back.It was noted that the first and second stents of the peripheral graft (vnmc3125c207) were damaged so they were disconnected from the graft and only those stents were cut.No further endoleaks were confirmed so the procedure was completed.The patients progress was noted as good.Per the physician the cause of the infection, damage to stents and the type iiib endoleak were undetermined but it was noted that the patient's condition might be caused by the fact that the blood vessel was brittle due to an infection.No additional clinical sequelae were reported and the patient is fine.

• 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: 15968157
• MDR Text Key: 305341055
• Report Number: 9612164-2022-04702
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2022

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: 06/17/2022
• Device Model Number: VNMC3125C207TJ
• Device Catalogue Number: VNMC3125C207TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/13/2022
• Date Device Manufactured: 06/17/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female