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); Occlusion (1984); Seroma (2069); Claudication (2550); Blood Loss (2597)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; outcomes of an iliac branch endoprosthesis using an ¿up-and-over¿ technique for endovascular repair of failed bifurcated grafts.Emanuel r.Tenorio, md, phd, gustavo s.Oderich, md, giuliano a.Sandri, md, jussi m.Kärkkäinen, md, phd, manju kalra, mbbs, randall r.Demartino, md, jill k.Johnstone, md, and fahad shuja, mbbs, https://doi.Org/10.1016/j.Jvs.2018.10.098.If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant stent graft systems were implanted in patients for the endovascular treatment of abdominal aortic aneurysms.The following adverse events were reported; dissection, blood loss, femoral wound seroma, occlusion, intervention, claudication.

• Brand Name: ENDURANT STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9557135
• MDR Text Key: 173907101
• Report Number: 9612164-2020-00108
• 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: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2020

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: 12/12/2019
• Initial Date FDA Received: 01/07/2020
• 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: 74 YR