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

Model Number	ETLW1620C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a 66mm diameter abdominal aortic aneurysm.The aortic neck was 46mm in length, 20mm in diameter proximally and 17mm in diameter distally.It was reported that a ct was done and showed that the endurant stent graft that was implanted on patient's right side does not have wall apposition.There was a type ib endoleak at the bottom of the pant leg on the anterior side.The right common iliac length is about 4cms.The physician placed an endurant limb on the patient's right with the intention to extend the stent graft from the flow divider to the internal artery.The physician landed the limb even with the already implanted left limb stent graft just below the flow divider and the end of the 124 stent graft landed approximately 1 cm from the internal iliac artery.The physician also coil embolized the internal iliac artery due to concern it could later result in a type ii endoleak.No other visible endoleak was present after the limb was placed.Per the physician, the cause of the event was due to not enough purchase of the existing stent graft and dilation of the vessel.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the reported distal type i endoleak could not be conclusively determined from the limited films provided.Pre-implant films, films at implant, earlier post-implant films, films at the time of the event ((b)(6) 2017), and additional films at the secondary intervention were not available for review and comparison.The images provided did not show contrast injection prior implant of the additional limb stent graft, so the reported distal type i endoleak could not be assessed.However, the images showed that the od of the distal bifurcate ipsi limb measured ~ 20 mm l-r.The post-implant sizing worksheet showed that the diameter of the right common iliac artery is currently ~ 20-18-16 mm from proximal to distal.It is possible that the right common iliac artery had dilatated since implant due to disease progression, which led to the distal type i endoleak.
Additional Manufacturer Narrative
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: 6616450
• Report Number: 2953200-2017-00931
• Device Sequence Number: 16344212
• Product Code: MIH
• UDI-Device Identifier: 00613994991638
• UDI-Public: 00613994991638
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/12/2017

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: 02/05/2016
• Device Model Number: ETLW1620C93E
• Device Catalogue Number: ETLW1620C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided; 06/12/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 06/13/2017; 10/04/2017
• 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: 61 YR