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

Model Number ETTF3636C70E

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Pain (1994); Swelling (2091); Injury (2348)

Event Date 07/15/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 110mm diameter abdominal aortic aneurysm.It was reported that, approximately 2 years post index procedure, the patient presented emergently with lower abdomen pain and swelling.Ct scan indicated a type iii endoleak.The patient received intervention with the implantation of an aui and a fem-fem bypass.As per the physician, the cause of the event is unknown.No additional clinical sequelae were reported, and the patient will be monitored.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• 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: 7756038
• MDR Text Key: 116202297
• Report Number: 2953200-2018-01139
• Device Sequence Number: 0
• 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,Followup,Followup
• Report Date: 11/20/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2018
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 11/08/2018
• Supplement Dates FDA Received: 10/02/2018; 11/20/2018
• Date Device Manufactured: 01/20/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR