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

Model Number	ETTF2828C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx endoanchoring system and an endurant ii stent graft cuff were used in the endovascular treatment of a type ia endoleak of the patient.The patient previously had an anuerx stent graft system implanted for the endovascular treatment of an abdominal aortic aneurysm approximately eight and a half years previously.It was reported that approximately a year and a half post the intervention procedure that patient presented emergently.A slight in crease in the aneurysm was identified (76mm to 84mm); with evidence of a type ia endoleak.The patient has decided to forgo treatment due to overall medical condition measure and was discharged from hospital and transferred to an inpatient hospice.The cause of the event is unknown.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received: it was reported that the type ia endoleak was assessed as possibly related to the stent graft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II EXTENSION CUFF
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7933155
• Report Number: 2953200-2018-01390
• Device Sequence Number: 13645581
• Product Code: MIH
• UDI-Device Identifier: 00613994991492
• UDI-Public: 00613994991492
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2018
• Device Model Number: ETTF2828C70E
• Device Catalogue Number: ETTF2828C70E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 03/13/2019
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 12/12/2018; 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 72