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

Model Number	ETBF3216C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	10/17/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system.Other relevant device(s) are: etlw1613c124e sn (b)(4), use by date: 2014-08-29, udi # (b)(4), etlw1613c124e sn (b)(4), use by date: 2014-08-29, udi # (b)(4), enew1313c82e sn (b)(4), use by date: 2014-01-16, udi # (b)(4).
Event or Problem Description
Heli-fx aptus endoanchor applier was selected for the prophylactic use, to prevent aortic neck dilatation, along with an endurant stent graft system for the endovascular treatment of a 6.7 cm in diameter abdominal aortic aneurysm.It was reported that on the same day as the procedure, the patient had hypertension that was treated with medication.The hypertension resolved.The investigator indicated that the cause of the hypertension is uncertain.No additional clinical sequelae were reported and the patient will be monitored by the investigator.

• 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: 6721907
• Report Number: 2953200-2017-01139
• Device Sequence Number: 13853445
• Product Code: MIH
• UDI-Device Identifier: 00613994990976
• UDI-Public: 00613994990976
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/23/2017

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: 08/28/2014
• Device Model Number: ETBF3216C124E
• Device Catalogue Number: ETBF3216C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/18/2017
• 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: 78 YR
• Patient Weight: 68