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

Model Number UNK-CV-SR-ENDUR-II

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

Patient Problems Hematoma (1884); Inflammation (1932); Thrombocytopenia (4431); Thrombosis/Thrombus (4440); Respiratory Insufficiency (4462)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information from a journal article entitled; comparison study of iliac branch endoprosthesis when used on and off label rodriguez l.E., eun j.C., calkins r.T., carroll a.M., malgor e.A., wohlauer m.V., nehler m.R., jacobs d.L., malgor r.D.Ann.Vasc.Surg.2023 feb 01; 89:28-35.Doi: 10.1016/j.Avsg.2022.03.015 a2.<(>&<)> if information is provided in the future, a supplemental report will be issued.

Event Description

A non mdt iliac branch endoprosthesis was implanted in a patient for the treatment of a ib endoleak in an endurant iis stent graft.Other patients were implanted with iliac branch endoprostheses to treat common iliac artery aneurysms.Patients were treated at two centers over a four year period and outcomes were compared between ifu and non ifu iliac branch endoprosthesis (ibe) cases.The treatment of the ib endoleak in the endurant stent graft was considered a off label technique.In the follow-up period in the non ifu group the following malfunctions were identified; type iii endoleaks the following adverse events were identified; one internal iliac artery limb thrombosis, hematoma, minor systemic complications ( mild respiratory insufficiency, 150% rise in cr eatinine, post implantation syndrome, and/or heparin induced thrombocytopenia which were managed medically), intervention patient mortality was reported but there is no causal link that an endurant stent graft caused or contributed to a death.

• Brand Name: ENDURANT II 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: 16813457
• MDR Text Key: 313989412
• Report Number: 9612164-2023-01772
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

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-ENDUR-II
• Device Catalogue Number: UNK-CV-SR-ENDUR-II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/26/2023
• 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: 67 YR
• Patient Sex: Male