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

Model Number	ETBF2813C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Injury (2348)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system.Other relevant device(s) are: product id: etlw1616c93e, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4).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 an abdominal aortic aneurysm of unknown size.It was reported that during patient follow up, a ct scan identified an occlusion.It was reported that the left side of the graft became occluded, with the occlusion beginning at the flow divider and extending through the external iliac artery.Blood flow is then resuming in the femoral artery.The physician attempted to perform a thrombectomy, but was unsuccessful and a fem-fem bypass was performed instead.The issue was resolved.Per the physician, the cause of the event is uncertain but the physician noted that the occlusion may have originated at the narrowing at the proximal left common iliac artery.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7800490
• Report Number: 2953200-2018-01181
• Device Sequence Number: 1928103
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: 00613994991294
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 03/27/2020
• Device Model Number: ETBF2813C145E
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/21/2018
• 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: 82 YR