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

Model Number	ETBF3620C166E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an unknown size abdominal aortic aneurysm.It was reported that approximately 3.5 years post index procedure a ct was performed revealing a a type ia endoleak.The physician elected to perform surgery to solve the endoleak.After angiogram it was determined that there was 7cm from the graft bifurcation to the sma and the type ia endoleak.As the patient was on dialysis, the physician was able to cover both renal arteries with a 36x36x70 aortic cuff which was placed inside the previous implanted bifurcate at the level of the sma.The cuff was then ballooned using a reliant balloon; however, after angiogram the endoleak was still visible.The physician decided then to place endoanchors inside the cuff but after placing 3 endoanchors the heli-fx applier froze and wouldn't work.A new heli-fx applier was opened and a further 16 endoanchors were placed.After this the endoleak was resolved and the case was completed.As per the physician, the cause of the event was anatomy related due to a large reverse cone neck.No additional clinical sequelae were reported and the patient is fine.

• 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: 7380644
• Report Number: 2953200-2018-00454
• Device Sequence Number: 1608058
• Product Code: MIH
• UDI-Device Identifier: 00613994991065
• UDI-Public: 00613994991065
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2016
• Device Model Number: ETBF3620C166E
• Device Catalogue Number: ETBF3620C166E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/29/2018
• 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: 73 YR