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

Model Number	ETBF2816C145E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Pain (1994); Injury (2348)
Date of Event	08/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: etlw1616c82e, serial/lot #: (b)(4), ubd: (b)(4) 2016, 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 a 50mm diameter abdominal aortic aneurysm.It was reported approximately 4 years post the index procedure the patient was presented emergently with back pain.The physician noted no visible endoleaks but the aneurysm has increased in size by at least 10mm.It was also noted that the stent graft was a few mm from the lowest renal artery and the right iliac limb was only into the cia a few mm.Therefore, on the same day, the physician inserted a 32mm endurant cuff and extended the right common iliac with a endurant stent graft limb.The proximal cuff was anchored via heli-fx endoanchors.The procedure was successful.Per the physician, the cause of the event is unknown.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: 7888580
• Report Number: 2953200-2018-01315
• Device Sequence Number: 2507504
• Product Code: MIH
• UDI-Device Identifier: 00613994991324
• UDI-Public: 00613994991324
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 10/19/2016
• Device Model Number: ETBF2816C145E
• Device Catalogue Number: ETBF2816C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2018
• Initial Report FDA Received Date: 09/19/2018
• 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: 83 YR