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

Model Number	ETLW1624C124E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 endovascular treatment of an abdominal aortic aneurysm.It was reported approximately 5 years post the index procedure, follow up ct identified a distal type ib endoleak with loss of seal.The limb has retracted out of the rcia and back into aneurysm.Per the physician the cause of the event is anatomy related due to disease progression.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film analysis summary: migration of the right limb out of the right common iliac artery, with resulting distal type i endoleak and aaa expansion, was confirmed from the returned films.The likely cause appears to be due to disease progression.Review of pre-implant ct¿s revealed that the patient had a 56mm max diameter infrarenal aaa.The proximal ranged in diameter from 23 ¿ 25mm along the 50mm neck length, and the neck was mildly angulated ~30 deg a-p.The iliac arteries were mildly tortuous with slight calcification, and the right common iliac artery was aneurysmal ranging in diameter from ~15 ¿ 23 ¿ 14 ¿ 19 mm.Recent ct¿s from 5+ years post-implant confirmed that the distal end of the contra limb appeared to have pulled out (migrated) from the right iliac artery and was positioned within the aaa sac.The maximum aaa diameter had increased to 65mm, and contrast was seen within the distal sac from the distal type ib endoleak coming from the right side.Due to the limb migration the contra limb was severely kinked posteriorly just distal to the contra gate with a resulting 7mm limb id.The distal right limb od measured 27mm within the unapposed aaa sac, and the right common iliac was aneurysmal ranging in diameter from 28 ¿ 22mm along the 4cm length.It appears most likely that disease progression, iliac artery dilatation, led to the limb migration out of the right iliac artery.If information is provided in the future, a supplemental report will be issued.

• 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; galway
• MDR Report Key: 8128416
• Report Number: 2953200-2018-01650
• Device Sequence Number: 18893192
• Product Code: MIH
• UDI-Device Identifier: 00613994991690
• UDI-Public: 00613994991690
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 03/08/2015
• Device Model Number: ETLW1624C124E
• Device Catalogue Number: ETLW1624C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR