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

Model Number VNMC4034C200TJ

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem Hemoptysis (1887)

Event Date 11/09/2021

Event Type  Injury  

Event Description

Valiant navion stent grafts were implanted during an endovascular procedure for the treatment of a 57mm thoracic aortic aneurysm.It was reported approximately 2 years post the index procedure the patient presented with haemoptysis.A ct identified aneurysm enlargement and evidence of stent ring enlargement.It also was observed that the junction of the stent graft come off.  as per the physician the cause of the event could not be determined.  no additional clinical sequelae was provided and the patient is fine.

Manufacturer Narrative

Other relevant device(s) are: product id: vnmc4646c55tj, serial/lot #: (b)(4), ubd: 01-sep-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received: it was confirmed that the original implanted device was not a navion device.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

Core lab review of ct imaging from 07-nov-2021 identified an new unknown endoleak.No stent fracture was observed on vnmc4646c55tj ((b)(6)).It was noted as non evaluable for stent fracture on vnmc4034c200tj ((b)(6)) due to device overlap.No stent ring en largement or stent ring displacement was identified.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: 12809792
• MDR Text Key: 280744914
• Report Number: 9612164-2021-04405
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2022

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: 09/15/2021
• Device Model Number: VNMC4034C200TJ
• Device Catalogue Number: VNMC4034C200TJ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 03/22/2022; 06/29/2022
• Supplement Dates FDA Received: 04/13/2022; 07/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1201-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male