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

Model Number UNK-CV-SR-ENDURANT

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: ENDURANT STENT GRAFT
• 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: 10790125
• MDR Text Key: 214749672
• Report Number: 9612164-2020-04245
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: P100021
• 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
• 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
• 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