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

Model Number	ETBF2316C124E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: product id: etlw1616c82e, serial/lot #: (b)(4), ubd: 23-nov-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of a 60mm abdominal aortic aneurysm.It was reported that the patient presented with left leg numbness at their follow up approximately 6 months post the index procedure.An angiogram was carried out on the patient and it was reported that the patient did not have any flow to their left leg.The implant had thrombosed at the bifurcation.The physician reported the cause of the event could not be determined.The patient was treated with a fem-fem bypass.No additional clinical sequelae were reported, and the patient is fine.

• 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: 7453508
• Report Number: 2953200-2018-00591
• Device Sequence Number: 1481909
• Product Code: MIH
• UDI-Device Identifier: 00613994991195
• UDI-Public: 00613994991195
• 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): 04/24/2018

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: 03/25/2018
• Device Model Number: ETBF2316C124E
• Device Catalogue Number: ETBF2316C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/24/2018
• 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: 67 YR