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

Model Number CV-SR-UNK-TALENT

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

Patient Problems Intimal Dissection (1333); Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Ischemia (1942); Occlusion (1984); Rupture (2208); Thrombosis/Thrombus (4440)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; outcomes of elective endovascular aneurysmal repair for abdominal aortic aneurysms in jordan janho e j , rashaideh a.M, shishani j, jalokh m haboub h vascular specialist internationalist 2019;35(4):202-20 https://doi.Org/10.5758/vsi.2019.35.4.202 if information is provided in the future, a supplemental report will be issued.

Event Description

Endurant, talent non mdt stent grafts were implanted in patients in the endovascular treatment of infra renal abdominal aortic aneurysms.The aneurysm were 64mm in diameter on average.The following malfunctions were observed; type ia, ib ii, iiia endoleaks, migration the following adverse events were observed; dissection, occlusion, hematoma, infection, thrombosis, fistula, rupture, thrombosis, ischemia re-intervention.Patient deaths were reported but there is no causal link that an mdt stent graft caused or contributed to these deaths.

• Brand Name: TALENT - UNK
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; IE ; 091708096
• MDR Report Key: 10790148
• MDR Text Key: 214723756
• Report Number: 9612164-2020-04246
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: P070027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/15/2020
• Initial Date FDA Received: 11/05/2020
• 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