MAUDE Adverse Event Report: ON-X LIFE TEHCNOLOGIES, INC. ON-X PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE

Model Number	ONXA
Health Effect - Clinical Codes	Death (1802); Thrombosis (2100); Patient Problem/Medical Problem (2688)
Date of Event	12/16/2015
Type of Reportable Event	Death
Additional Manufacturer Narrative
There is no explant date.The autopsy did not include explanting the valve, so it remains within the deceased.The autopsy did not include explanting the valve, so it remains within the deceased, and is therefore not available to be returned.The device history record was reviewed and it was determined that the valve was built per specifications.
Event or Problem Description
Dr.(b)(6), (b)(4).Medical director, reported to on-x that he had been reviewing records of a (b)(6) vascular donor who had received a 27mm on-x valve in 2007.The patient was doing well after the heart valve surgery, but died suddenly on (b)(6) 2015.The autopsy showed an acute thrombus in a coronary artery.Patient had no significant coronary artery disease.The autopsy does not specifically allege that the valve was the source of the thrombus, but of course that is one of the known risks for mechanical valves.Throughout the patient's medical records, the heart valve is shown to function normally.The on-x valve was not explanted, remains within the deceased.This is being reported because it is defined as a valve-related adverse event per aats/sts guidelines, and is among a list of adverse events possible with heart valve patients as listed in section 5 of the ifu.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TEHCNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• MDR Report Key: 5539435
• Report Number: 1649833-2016-70019
• Device Sequence Number: 16232360
• Product Code: DYE
• UDI-Device Identifier: 00851788001259
• UDI-Public: 00851788001259
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

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: 07/18/2011
• Device Model Number: ONXA
• Device Catalogue Number: ONXA-27/29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2016
• Initial Report FDA Received Date: 03/31/2016
• 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: 23 YR
• Patient Weight: 97