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

Model Number	ETUF3614C102E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: information references the main component of the system.Other relevant device(s) are: product id: etlw1620c93e, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A talent stent graft system was implanted in a patient for the endovascular treatment of an unknown size abdominal aortic aneurysm.It was reported that the patient presented emergently in pain approximately 8 years post the index procedure.A ct revealed an unknown endoleak appearing most prominent at the level of the unsupported segment of the right limb.It was noted that the effectiveness/length of the proximal seal as well as the distal right limb seal would suggest that these areas are compromised and may be the source of the leak.Radiology has read the patient ct and concluded a type iii endoleak.Intervention was completed and a classic angiogram was done where the physicians agreed this was a type iii endoleak at the level of the unsupported segment.A 36mm aui was implanted and extended with a 20mm flared limb.A small endoleak at final run was observed that the physicians felt would resolve.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Films review summary the exact cause and source of the reported endoleak, later confirmed by angiography to have been a type iii fabric endoleak near the unsupported area of the ipsilateral limb, could not be determined from the limited returned films.The anatomy at implant is unknown, earlier post-implant films and follow-up history was not reported, and complete recent ct¿s or angiograms showing the reported endoleak were not available for review.Two (2) coronal ct slice images and a single transverse ct slice from an unknown study date revealed that a talent aaa system had been implanted in the patient.There was a bi-lobal infrarenal aaa with widespread contrast seen outside the stent graft; however, the source of the contrast could not be determined.The stent grafts were patent, essentially straight, and no other obvious stent graft issues were observed from these limited slices.Analysis of the returned films did not reveal any device or anatomical characteristics that could explain the reported type iii fabric endoleak.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7600335
• Report Number: 2953200-2018-00842
• Device Sequence Number: 233107
• Product Code: MIH
• UDI-Device Identifier: 00643169232631
• UDI-Public: 00643169232631
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2020
• Device Model Number: ETUF3614C102E
• Device Catalogue Number: ETUF3614C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/21/2018; 08/08/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/11/2018; 10/03/2018
• 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: 84 YR