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

Model Number	ETTF3636C70E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Off-label, unapproved or contraindicated use (aortic neck angulation) film evaluation summary: the exact cause of the reported migration leading the proximal type i endoleak, and the residual proximal type i endoleak after implant of the cuff cannot be conclusively determined from the three still angio images provided.Pre-implant anatomy information, films at implant, earlier post-implant films, and additional films during the secondary intervention were not provided for review and comparison.The bifurcate location at implant was unknown.However, the images provided showed that the bifurcate is currently ~ 2 cm below the right renal artery, and that the vessel diameter surrounding the proximal margin of the bifurcate was larger than the bifurcate itself.The aortic neck to the bifurcate main body was highly angulated.It is possible that there had been aortic neck dilatation and/or morphology changes since implant caused by disease progression.The aortic neck dilatation and the high aortic neck angulation may have contributed to the reported bifurcate migration and proximal type i endoleak.It is possible that implanting the endurant cuff in a highly angulated aortic neck may have prevented the cuff to oppose to the aortic neck, which led to the possible residual proximal type i endoleak.
Event or Problem Description
A talent stent graft system was implanted in the patient for the endovascular treatment of a 60 mm in diameter abdominal aortic aneurysm.It was reported that, approximately six years and nine months post index procedure the talent stent graft had migrated and had a proximal type i endoleak.The physician elected to implant an endurant aortic cuff and eight aptus endoanchors as part of the planned procedure.The proximal type i endoleak was reduced by approximately 50% to 60% and the procedure was completed.Per the physician, the cause of the event was due to disease progression.In addition, the physician attributed the persistent type ia endoleak due to the graft not being able to reach the aortic wall due to the migrated position of the talent stent graft.No additional clinical sequelae were reported and the patient is being monitored by their physician.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6266790
• Report Number: 2953200-2017-00078
• Device Sequence Number: 844351
• Product Code: MIH
• UDI-Device Identifier: 00613994991515
• UDI-Public: 00613994991515
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/28/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2017
• Device Model Number: ETTF3636C70E
• Device Catalogue Number: ETTF3636C70E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: 12/28/2016
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR