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

Model Number UNK-CV-SR-VALIANT

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

Patient Problems Arrhythmia (1721); Dyspnea (1816); Pain (1994); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 09/15/2021

Event Type  Death  

Event Description

Valiant navion stent grafts were implanted during the endovascular treatment of a 60mm descending thoracic aortic aneurysm (taa) on an unknown date in 2007.A non mdt stent graft was implanted to treat a 50mm infrarenal aaa.It was reported approximately 2 years post the index procedure follow up echo demonstrated the patient had developed symptomatic of left ventricular hypertrophy with diastolic dysfunction.The patient had bilateral lower limb oedema, with on and off chest pain and shortness of breath.On further follow up the patient had developed q-t interval with resultant new-onset atrial fibrillation.It was reported 9 years post the index procedure the patient expired due to fatal cardiac arrhythmia.

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; combined thoracic endovascular aortic repair and endovascular aneurysm repair and the long-term consequences of altered cardiovascular haemodynamics on morbidity and mortality: case series and literature review sultan et al, european heart journal - case reports (2021) 5(10), 1¿10 case reports (2021) 5(10), 1¿10 doi:10.1093/ehjcr/ytab339.Other relevant device(s) are:s/n: unknown; use by date: unknown; upn # unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

B5; correction to ed; valiant stent grafts were implanted during the endovascular treatment of a 60mm descending thoracic aortic aneurysm (taa) on an unknown date.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 STENT GRAFT
• 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: 13024017
• MDR Text Key: 282378311
• Report Number: 9612164-2021-04908
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P100040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-VALIANT
• Device Catalogue Number: UNK-CV-SR-VALIANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/03/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Male