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 Code	Urinary Retention (2119)
Date of Event	12/14/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant devices are: etlw1610c93e , s/n: (b)(4); use by date: (b)(6) 2014; upn # (b)(4).Etew1313c82e , s/n: (b)(4); use by date: (b)(6) 2014; upn # (b)(4).
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of a 50mm in diameter abdominal aortic aneurysm.Five heli-fx endoanchors were also implanted from the main body of the stent graft to the proximal neck during the index procedure for concern for late failure.It was reported that two days post procedure, the patient developed urinary retention determined to be related to the procedure.The patient received treatment with medication and catheterization and the event resolved.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: 7159539
• Report Number: 2953200-2018-00009
• Device Sequence Number: 1447622
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: 00613994991294
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/03/2018

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: 08/23/2014
• Device Model Number: ETBF2813C145E
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 01/03/2018
• 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: 69 YR
• Patient Weight: 79