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

Model Number	ETLW1620C124E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the left/contra limb migration out of the left common iliac artery could not be determined from the pre-implant films provided.Films during implant and current ct¿s were not available for review, and the reported migration event could not be assessed.Review of a pre-implant film report revealed that the patient had a 63mm max diameter infrarenal aaa.The proximal neck diameter measured 24mm along a 20mm length, and the neck was moderately angulated to ~55deg and mildly calcified.Both common iliac arteries were moderately tortuous, calcified and short.The left common iliac artery diameter ranged from 21 ¿ 14mm as it coursed distally along a 21mm length.It appears likely that disease progression, with iliac artery dilatation currently to 22 ¿ 17mm in diameter, combined with the short iliac artery length, led to the reported the lack of distal seal and limb migration.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 63mm abdominal aortic aneurysm.Following a ct scan carried out approximately 6 years later it was reported that the contralateral limb in the left common iliac appeared to have migrated proximally into the sac of the aneurysm and was no longer in the left common iliac where it was originally implanted.The physician reported the cause of the event to be anatomy related.Because the length of the left common iliac artery was only 22mm and the diameter of the left common iliac artery was already a diameter of 14-20mm the patient experienced some disease progression of the left common iliac artery whereby the left common iliac artery diameter was now 17-22mm and that the contralateral limb lost it's wall apposition.An intervention procedure was carried out a month later.The left internal iliac artery was embolized and an iliac extension limb was implanted that overlapped with the existing contralateral limb into the left external iliac artery.The event was reported to be resolved following the intervention procedure.No additional clinical sequelae were reported, and the patient is fine.

• 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: 7577068
• Report Number: 2953200-2018-00819
• Device Sequence Number: 2527194
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 06/05/2014
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/07/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR