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

Model Number UNK-CV-SR-ENDURANT

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

Patient Problem Myocardial Infarction (1969)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; arterial stiffness assessed by cardio-ankle vascular index in patients with abdominal aortic aneurysm and its alterations after treatment mylonas sn, moulakakis kg, kadoglou n, et al.Vascular and endovascular surgery.2021;55(8):804-810.Doi:10.1177/15385744211023281.If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant and talent stent grafts and non mdt stent grafts were implanted in the endovascular treatment of abdominal aortic aneurysms on unknown dates.The following adverse events were reported; myocardial infraction patient mortality was reported but there is no causal link that a mdt stent graft caused or contributed to a death.

• Brand Name: ENDURANT 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: 13024759
• MDR Text Key: 282385108
• Report Number: 9612164-2021-04918
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100021
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-SR-ENDURANT
• Device Catalogue Number: UNK-CV-SR-ENDURANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG