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

Model Number	ONXACE
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	03/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"serious injury" chosen because this was an expected adverse event that required the patient to endure a re-operation, which is similar to a serious injury for this procedure.This adverse event was discovered after the event and the hospital had disposed of the valve, so could not evaluate it.The device history record was reviewed and the valve was found to have been built per specifications.
Event or Problem Description
While entering tracking database implant information, a patient was observed to have received a second implant of the same position (aortic).The surgeon's office was contacted and it was reported that the re-operation was due to prosthetic endocarditis.No other information available.Valve is not available for return.This is being reported because endocarditis is defined in the aats/sts guidelines as valve-related and reportable, therefore it is being reported.It is listed among expected adverse events that can occur for a heart valve patient in section 5 of the ifu.It is occurring within expected frequency, no trends are seen.

• 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: 5614631
• Report Number: 1649833-2016-70026
• Device Sequence Number: 10812788
• Product Code: DYE
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2016

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: 04/16/2021
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 04/28/2016
• 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: Required Intervention
• Patient Age: 48 YR