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

Model Number	ETBF2516C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the proximal type i endoleak could not be determined from the films provided.The anatomy at implant is unknown, and earlier follow-up images were not available for return and comparison.Ct¿s returned from 11 months post-implant revealed that the endurant ii bifurcate was positioned ~5mm below the lowest left renal artery near the bottom of the remaining proximal neck.Ten (10) mm¿s below the left renal the bifurcate diameter was 25mm, and there was lack of stent graft radial apposition within the aorta which measured >30mm in diameter, and there was a resulting type ia endoleak.There appeared to be adequate distal sealing; bilaterally.The cause of the proximal type i endoleak appears most like due to an inadequate proximal seal caused by a non-existent proximal neck.It is possible that the short (5mm) remaining neck length was caused by disease progression, and it is unclear if the stent graft may have migrated since the original location of the implanted bifurcate is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 51mm diameter abdominal aortic aneurysm.It was reported that the patient was presented emergently approx.1-year post index procedure.A ct scan revealed a type ia endoleak.Per the physician, the cause of the event cannot be determined.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.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7801505
• Report Number: 2953200-2018-01189
• Device Sequence Number: 1862157
• Product Code: MIH
• UDI-Device Identifier: 00613994991270
• UDI-Public: 00613994991270
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 05/11/2019
• Device Model Number: ETBF2516C166E
• Device Catalogue Number: ETBF2516C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR