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

Model Number	ETLW1616C93E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in the patient for the endovascular treatment of a 65 mm in diameter abdominal aortic aneurysm approximately two years and seven months post index procedure, a ct revealed that the left common iliac artery had dilated and there was a possible distal type i endoleak.The patient had an angiogram.The physician elected to coil the left hypogastric artery and to extend the existing endurant stent graft into the left external iliac artery.The procedure went as planned and the left common iliac artery aneurysm was sealed.Per the physician, the cause of the event was unknown.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 determined from the films provided.A single pre-implant coronal ct scan slice revealed that the patient had a infrarenal aaa which measured 65.5mm in maximum diameter.No baseline images of the iliac arteries were seen and the pre-implant anatomy could not be completely assessed.Films during implant and earlier post-implant were also not available for review and comparison.Non-contrast images from 30 months post-implant confirmed that the aaa diameter had increased to 79mm, and there was a possible distal type i endoleak due to lack of distal seal between the left limb and aneurysmal left common iliac.The distal od of the left limb measured ~17mm, and the iliac artery diameter at that same level was ~31mm.It is possible that the distal type i endoleak was due to disease progression; iliac artery dilatation.Films from the reported intervention to extend the existing endurant stent graft into the left external iliac artery were not available.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.

• 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: 6766332
• Report Number: 2953200-2017-01233
• Device Sequence Number: 1412693
• Product Code: MIH
• UDI-Device Identifier: 00613994991584
• UDI-Public: 00613994991584
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/14/2017

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: 08/21/2015
• Device Model Number: ETLW1616C93E
• Device Catalogue Number: ETLW1616C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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: 63 YR