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

Model Number VAMF3030C150TJ

Device Problem Leak/Splash (1354)

Patient Problems Hemoptysis (1887); Insufficient Information (4580)

Event Date 09/17/2021

Event Type  Injury  

Event Description

A valiant navion stent graft system was implanted during an endovascular procedure.The valiant navion was implanted to treat an unknown endoleak on a previously implanted unknown valiant stent graft.It was believed that the leak was resolved at the time it was reported that on that an unknown endoleak was observed on an unknown date.An intervention was carried out where a non-mdt device  was implanted and the type endoleak could not be determined during the procedure.At the time the patient had developed hemoptysis.A leak was observed on the periphery neck on ct but it was not observed on aortography.The physician suspected that a type iii endoleak occurred.It was reported that the endoleak type has not been determined.The physician suspects that a type ia or iiib endoleak had occurred.No cause of the event was reported.No additional clinical sequalae was provided and the patient will be monitored.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received: it was confirmed that the original valiant device vamf3030c150tj/v07611769 was implanted on (b)(6) 2018.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.

• Brand Name: VALIANT CAPTIVIA - FF
• 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: 12889450
• MDR Text Key: 281396779
• Report Number: 9612164-2021-04617
• 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,Followup
• Report Date: 02/14/2022

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: 03/04/2020
• Device Model Number: VAMF3030C150TJ
• Device Catalogue Number: VAMF3030C150TJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 02/14/2022
• Date Device Manufactured: 03/05/2018
• 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 Age: 84 YR
• Patient Sex: Female