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	Abdominal Pain (1685)
Date of Event	03/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: etew2020c82e sn (b)(4), expiration date: 2015-07-15, udi # (b)(4).Film evaluation summary: the exact cause of the contra limb migration leading to distal type i endoleak cannot be conclusively determined from the five still images provided.Pre-implant anatomy information, films at implant, earlier post-implant films, and additional films that showed the limb migration and distal type i endoleak were not provided for review and comparison.The limb location at implant was unknown.The images provided showed that the contra limb had pulled out from the left common iliac artery and is currently sitting in the distal aneurysm sac.Contrast was feeding the distal aneurysm sac from a distal type i endoleak.The left common iliac artery appeared aneurysmal and contained moderate amount of thrombus.It is possible that the left common iliac artery may have dilated since implant due to disease progression, which may have contributed to the events.A good faith effort will be made to obtain the applicable information relevant to the report.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 aortic aneurysm.It was reported that the patient presented emergently with abdominal pain.A ct revealed that the previously implanted endurant limb had retracted up into the aneurysm and there was no longer any seal in the left common iliac artery.The physician relined the entire left side of the graft into the left external iliac artery.The final angiogram showed that the endoleak had been sealed off and the event had resolved.The physician stated that the cause of the event could not be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.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: 6447753
• Report Number: 2953200-2017-00493
• Device Sequence Number: 16538367
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/04/2017

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: 12/12/2015
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2017
• Initial Date Received by Manufacturer: 03/04/2017
• Supplement Date Received by Manufacturer: 03/04/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 75 YR