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

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic received the following information from the journal article entitled; impact of stent-graft oversizing on gutter areas after chimney graft repair for complex abdominal aortic aneurysms.Romain de blic, frederic cochennec, faris alomran, hicham kobeiter, eric allaire, pascal desgranges and jean-pierre becquemin ann vasc surg 2018; 51: 200¿206 doi.Org/10.1016/j.Avsg.2018.02.040.If information is provided in the future, a supplemental report will be issued.

Event Description

Endurant stent grafts were implanted into patients in conjunction with chimney grafts for the endovascular treatment of complex abdominal aortic aneurysms, and type i endoleaks after standard evar.The following events were observed: malfunction: type ia endoleak stent graft kink.

• Brand Name: UNK-CV-SR-ENDURANT
• 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: 7808280
• MDR Text Key: 117960552
• Report Number: 2953200-2018-01195
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 08/23/2018
• 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