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

Model Number	ETLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the patient presented with abdominal pain.A recent ct revealed that there was a distal type i endoleak from the left common iliac and a proximal type i endoleak.The physician implanted two plugs from another manufacturer in left hypogastric artery and implanted an endurant stent graft from the original endurant stent graft down into left external artery.The distal type i endoleak was resolved.The physician elected to implant heli-fx aptus endoanchors in the proximal aortic neck.The proximal type i endoleak was resolved.Per the physician, the cause of the events is related to patient anatomy due 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 proximal type i and distal type i endoleak could not be determined from the limited films provided.The anatomy at implant is unknown, and earlier post-implant films <(><<)>(><(>&<)><(><<)>)> complete ct¿s were not available for return.Review of a 3d-ct film report from 28 months post-implant ((b)(6) 2017) revealed that the bifurcate was positioned just below the renal arteries, and a proximal type i endoleak was observed from the posterior side of the bifurcate.No scale was seen on the films and the neck diameter at the level of the endoleak could not be determined.Possible contrast was also seen outside the distal contra/left limb; however, it is unclear if the possible distal type i endoleak may have been pressurizing the aaa.The neck, aortic body, and iliac limbs were all essentially straight.The distal left limb od measured 20mm, which is the nominal limb od.It is possible that both the proximal and distal type i endoleaks were caused by disease progression; vessel dilatation.Images after implant of the endoanchors and endurant iliac limb, which reportedly resolved both endoleaks, were not available for review.
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: 6562308
• Report Number: 2953200-2017-00771
• Device Sequence Number: 10964812
• Product Code: MIH
• UDI-Device Identifier: 00613994991645
• UDI-Public: 00613994991645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/18/2017

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: 09/21/2016
• Device Model Number: ETLW1620C124E
• Device Catalogue Number: ETLW1620C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided; 05/18/2017
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 06/05/2017; 10/03/2017
• 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