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

Model Number	ETLW1613C93E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other relevant device(s) are: (catalog number: esbf2314c103e, serial number: (b)(4), use by date 2019-10-17 and upn# (b)(4)).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant stent graft system was implanted for the endovascular treatment of a 6.1cm abdominal aortic aneurysm.It was reported that the patient had an occlusion which extended from the right limb up into the bifurcation device.As per the physician, the cause of the event is anatomy related caused by calcified arteries with poor outflow.The patient received treatment with limb thrombectomy and stent placement.No additional clinical sequelae were reported and the patient is fine.

• 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: 7203314
• Report Number: 9612164-2018-00095
• Device Sequence Number: 853909
• Product Code: MIH
• UDI-Device Identifier: 00643169467682
• UDI-Public: 00643169467682
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/18/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/18/2018
• 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: 74 YR