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

Model Number	ENLW1628C124E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/27/2016
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 stent graft system was implanted in a patient for the endovascular treatment of a 7.1 x 7.5 cm abdominal aortic aneurysm.The left iliac artery was 22, 21, 20 mm in diameter from proximal to distal.The left external iliac artery was 7 mm ¿ 6 mm in diameter and it was 28 mm in length from the left internal iliac to a bend.The right iliac artery was 10 mm in diameter.It was reported that there was a right limb occlusion which required the patient to have a fem-fem bypass procedure to be performed.The physician stated that the cause of the event related to patient anatomy; specifically, small and tortuous iliac arteries.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 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: 6570515
• Report Number: 2953200-2017-00788
• Device Sequence Number: 10919580
• Product Code: MIH
• UDI-Device Identifier: 00613994762177
• UDI-Public: 00613994762177
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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: 04/25/2013
• Device Model Number: ENLW1628C124E
• Device Catalogue Number: ENLW1628C124E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 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: 70 YR
• Patient Weight: 87