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

Model Number CV-SR-UNK-TALENT

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

Patient Problems Stroke/CVA (1770); Ischemia (1942); Renal Failure (2041); Sepsis (2067); Rupture (2208); Respiratory Failure (2484); Pseudoaneurysm (2605); Multiple Organ Failure (3261)

Event Date 01/31/2022

Event Type  Injury  

Event Description

Talent stent grafts were implanted during the hybrid debranching endovascular repair of the aortic arch and proximal descending thoracic aorta on unknown dates.Non mdt devices were also implanted.The following adverse events were reported: aortic rupture, respiratory failure, sepsis with multi-organ failure, ventricular fibrillation, major stroke, renal failure, pseudoaneurysm, lower extremity ischemia, the overall in-hospital mortality rate was 5%.There was no information to suggest any of the valiant or talent device failures caused or contributed to the deaths.The cause of the adverse events are undetermined.

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled: mid-term outcomes of hybrid debranching endovascular aortic arch repair in landing zones 0¿2 eleshra et al, vascular 2023, vol.31(3) 447¿454 doi: 10.1177/17085381211068230 a2: mean age a3: mean gender d6a: exact date of implant unknown there was no information to suggest any medtronic device failure caused or contributed to a death.Deaths are common occurrences however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable as mdr or vigilance unless clearly stated as being associated with medtronic product.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: TALENT - UNK
• 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: 18065276
• MDR Text Key: 327283580
• Report Number: 9612164-2023-05011
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P070007
• 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
• Report Date: 11/03/2023

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: CV-SR-UNK-TALENT
• Device Catalogue Number: CV-SR-UNK-TALENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/03/2023
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male