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

Model Number	ETLW1613C199E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fever (1858)
Date of Event	03/28/2017
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 a 48 mm diameter abdominal aortic aneurysm and iliac artery aneurysm.It was reported that the internal iliac was embolized with another manufacturer¿s occluder before the endurant stent graft was implanted.The patient came in for the 30 day follow up and the scan revealed almost complete aaa thrombosis and two lumbar arteries were still patent.It was reported that the patient presented 12 days later to an er with fever and chills.Another scan was done and revealed an area of infection or an abscess.The patient was transferred from the original facility to another facility for further treatment.The physician stated that the area of concern is with the other manufacturer¿s occluder plug.The physician decided to explant the other manufacturer¿s occluder plug due to the infection.The endurant iliac limb was partial explanted and the iliac artery was ligated on the right side, then a fem-fem bypass was done to perfuse both iliac arteries.Per the physician, the other manufacturer¿s occluder device and the endurant iliac limb were both sent out for analysis and the results came back as the other manufacturer¿s occluder device was positive for infection and the endurant iliac limb was negative for infection, therefore the physician stated that the infection was related to the other manufacturer¿s occluder device.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 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: 6524777
• Report Number: 2953200-2017-00686
• Device Sequence Number: 476010
• Product Code: MIH
• UDI-Device Identifier: 00643169467705
• UDI-Public: 00643169467705
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: ETLW1613C199E
• Device Catalogue Number: ETLW1613C199E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2017
• Supplement Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 77 YR
• Patient Weight: 94