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

Model Number	ETLW1628C156E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: product id: etlw1628c124e, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4).Film evaluation summary: from the films provided it appears likely that the cause of the common iliac artery dilatation was due to disease progression.Pre-implant ct¿s returned revealed that the patient had a 64mm max diameter infrarenal aaa, and the common iliac arteries were of large caliber bilaterally.The right common iliac artery diameter ranged from 19 ¿ 20 ¿ 25 ¿ 22 mm, and the left common iliac ranged in diameter from 20 ¿ 27 ¿ 23 ¿ 22mm.Review of ct¿s and a 3d film report from 27 months post-implant that the bifurcate was positioned 5 ¿ 10mm below the renal arteries and there was 3 ¿ 4cm of proximal seal length.The maximum diameter aaa measured ~7cm and no clear contrast was observed within the aaa sac.However, there appeared to be lack of limb apposition with the iliac arteries, as contrast was seen filling the aneurysmal common iliac arteries near the distal end of the 28mm limbs; bilaterally.Both common iliacs had increased in diameter.The max diameter aneurysmal rcia measured 38mm and the lcia measured 51mm.Although no clear contrast was seen filling the aaa sac, it is possible that the aaa was also being pressurized via the marginal distal seal within the iliac limbs.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the treatment of a 56 mm abdominal aortic aneurysm.It was reported that a bilateral iliac aneurysm was observed on (b)(6) 2018 following a follow up ct scan of the patient.The physician reported the cause of the event could not be determined.No additional clinical sequelae were reported, and the patient is being monitored.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; parkmore business park west
• MDR Report Key: 7560341
• Report Number: 2953200-2018-00800
• Device Sequence Number: 19243826
• Product Code: MIH
• UDI-Device Identifier: 00643169467446
• UDI-Public: 00643169467446
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: 10/13/2017
• Device Model Number: ETLW1628C156E
• Device Catalogue Number: ETLW1628C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR