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

Model Number UNK-CV-SR-TAL TAA

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  malfunction  

Event Description

Talent and valiant stent grafts were implanted in thoracic endovascular aortic repairs on unknown dates over a 22 year period.  153 studies were included in this systematic review.  the patients in the studies underwent either fenestrated thoracic endovascular aortic repair (ftevar) or chimney thoracic endovascular aortic repair ( ch-evar) of aortic disease.The following malfunctions were reported:  type ia endoleak, migration, deformation in vivo  the following adverse events were reported;  stroke, occlusion  patient mortality was reported but there is no causal link that a mdt stent graft caused or contributed to any death.

Manufacturer Narrative

Medtronic received the following information from a journal  article entitled: comparison of chimney and fenestrated techniques for supraaortic branch revascularization during thoracic endovascular aortic repair: a systematic review and meta-analysis mingyu liu , xinyi wu ,  song wu,  xinyang li , shijie xin,  jian zhang cardiovascular  interventional  radiology  (2023) 46:1315¿1328 https://doi.Org/10.1007/s00270-023-03537-4 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.

• 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: 19134011
• MDR Text Key: 341005691
• Report Number: 9612164-2024-01871
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/11/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 59 YR