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

Model Number VAMF2828C100TE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hematoma (1884); Pain (1994); Vascular Dissection (3160)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

A valiant captivia stent graft was implanted during endovascular treatment of a thoracic aortic aneurysm.It was reported approximately 5 months after the index procedure, the patient experienced back and chest pain, which increased 2 days later to a constrictive pain, sweating and nausea requiring the patient to be hospitalized. a follow up angio scan performed 5 days after the beginning of symptoms, revealed a stable hematoma of the periprosthetic descending thoracic aorta with a type b dissection measuring at 47 mm in the proximal third of the descending thoracic aorta, without extension to the arch or supra-aortic trunks.Well-permeable visceral collaterals vessels were noted with no signs of visceral hypoperfusion and almost complete thrombosis of the periprosthetic false duct. there was no indication for emergency surgery, and the patient was managed clinically with ct scan monitoring during hospitalization, blood pressure control, and treatment with concomitant medication.The patient was discharged 13 days after the beginning of the reported symptoms.The sponsor assessed the type b dissection as not related to the procedure but related to the device study.No additional clinical sequalae were provided and the patient will be monitored.

Manufacturer Narrative

B5; additional information received : it was reported the dissection was probably linked to a significant increase in blood pressure.The dissection resolved over two months later.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VALIANT CAPTIVIA - FF
• Type of Device: 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: 19018160
• MDR Text Key: 339085744
• Report Number: 9612164-2024-01546
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: VAMF2828C100TE
• Device Catalogue Number: VAMF2828C100TE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/15/2024
• Date Device Manufactured: 07/20/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 39 KG