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

Model Number UNK-CV-SR-ENDURANT

Device Problems Leak/Splash (1354); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; strategies and outcomes for aortic endograft explantation.Failure of endovascular aneurysm repairs (evars) requiring open conversion remains a major challenge.Dean j.Arnaoutakis, md, mba, gaurav sharma, md, stuart blackwood, md, samir k.Shah, md, matthew menard, md, c.Keith ozaki, md, and michael belkin, md, gainesville, fla; and boston, mass.September 8-10, 2017, doi.Org/10.1016/j.Jvs.2018.03.426.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 on an unknown date.The following adverse events were reported: malfunction: type i, type ii, type iii & type v endoleaks and occlusion/kinking.

• 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: 7662136
• MDR Text Key: 113188147
• Report Number: 2953200-2018-00946
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2018

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
• 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: 06/25/2018
• Initial Date FDA Received: 07/04/2018
• 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
• Patient Age: 76 YR