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

Model Number	ETLW1616C156E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Abdominal Pain (1685); Injury (2348)
Date of Event	03/22/2018
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 stent graft system was implanted in a patient for the endovascular treatment of a 100mm abdominal aortic aneurysm.It was reported that the patient presented emergently with abdominal pain approximately 3.5 years post the index procedure.A type 1b endoleak was identified in the patient.The physician treated the patient by embolizing the left internal iliac and then placing a vbx stent sealing from the stent graft into the left external iliac.The physician attributed the cause of the event to disease progression.No additional clinical sequelae were reported, and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the reported distal type i endoleak could not be determined from the limited films provided.Two still angiograms during an intervention (unknown date) were returned.No scale was seen on the films; therefore, no stent graft or vessel measurements could be performed.The 1st non-contrast image showed both iliac limbs.However, as the films were non-contrast no assessment of any endoleak or stent graft/vessel patency could be performed.The left limb showed slight stent graft compression ~3cm from the distal end, near to where the limb was angulated ~45 deg, and no stent graft issues were observed.The 2nd image showed that another manufacture¿s stent had been implanted distal to the endurant limb, extending past the left hypogastric artery which had been embolized and into the left external iliac.The devices were patent, and no clear endoleak or any other issues were observed.The anatomy at implant is unknown, earlier post-implant films were not provided, and more complete current films were also not available.From the two still angiograms returned, assessment and cause of the reported endoleak could not be determined.It is possible that this event was due to disease progression; iliac artery dilatation.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: 7439257
• Report Number: 2953200-2018-00568
• Device Sequence Number: 13739177
• Product Code: MIH
• UDI-Device Identifier: 00613994991607
• UDI-Public: 00613994991607
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/29/2018

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: 02/05/2016
• Device Model Number: ETLW1616C156E
• Device Catalogue Number: ETLW1616C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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: 85 YR