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

Model Number UNK-CV-SR-TAL TAA

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Ischemia (1942); Renal Failure (2041); Sepsis (2067); Rupture (2208); Respiratory Failure (2484); Vascular Dissection (3160)

Event Date 01/30/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal entitled; haji-zeinali am, mansouri p, raeis hosseini n, abbasi k, shirzad m, jameie m, haji-zeinali mm.Five-year survival and complications of thoracic endovascular aortic repair (tevar): a single tertiary center registry for all-comers patients.Cardiovasc revasc med.2023 jun;51:23-30.Doi: 10.1016/j.Carrev.2023.01.020 a.2 a.3 average.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 , talent and non mdt stent grafts were implanted in tevar procedures over a 10 year period.123 patients were included in the study.Various aortic pathologies were treated included aneurysms, dissections and pseudoaneurysms.  the following malfunctions were reported;  type i, type iii, iv  endoleak, migration  the following adverse events were reported;  spinal cord ischemia, bowel ischemia, blood loss, cva, dialysis, sepsis, pulmonary complications, rupture, dissection, myocardial infraction, re-intervention  patient mortality was reported but there is no causal link that a mdt stent graft caused or contributed to any death.

• Brand Name: TALENT TAA 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: 18235923
• MDR Text Key: 329315720
• Report Number: 9612164-2023-05686
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P070007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

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-TAL TAA
• Device Catalogue Number: UNK-CV-SR-TAL TAA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/30/2023
• 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): Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male