MAUDE Adverse Event Report: ON-X LIFE TEHCNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS; VALVED CONDUIT

Model Number	ONXAAP
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	04/16/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device not available for return, presummably remains implanted in the deceased.Review of device history record shows device was built per specifications.
Event or Problem Description
While entering device implant information, it was necessary to verify the patient's last name.In an internet look-up, it was learned the patient had passed away on (b)(6) 2016.The hospital was contacted to find out cause of death.The original surgery on (b)(6) 2016 was for repair of a pseudo-aneurism.During the surgery, the aneurism ruptured.Upon entering the chest, the patient needed to be maintained by ecmo (extracorporeal membrane oxygenation) and could not be weaned from the bypass.This care needed a lot of staff around the clock and the implanting location could not continue to provide it because it is a smaller hospital.The patient was transferred to a larger (b)(6) facility in (b)(6) on (b)(6) 2016, where the patient passed away on saturday (b)(6) 2016.Attempts were made to get information as to cause of death, with no success as (b)(6) law has barriers that interfered with getting this information.This is being reported in the event it is actually reportable, and not due to complications of the surgery not directly related to the device.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS
• Common Device Name: VALVED CONDUIT
• Manufacturer (Section D): ON-X LIFE TEHCNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• MDR Report Key: 5624373
• Report Number: 1649833-2016-70028
• Device Sequence Number: 10765592
• Product Code: DYE
• UDI-Device Identifier: 00851788001525
• UDI-Public: 00851788001525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2016

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: Lay User/Patient
• Device Expiration Date: 06/01/2016
• Device Model Number: ONXAAP
• Device Catalogue Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 05/02/2016
• 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: Death
• Patient Age: 56 YR