MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 27/29MM; MECHANICAL HEART VALVE

Model Number	ONXM-27/29
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/30/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No information is available regarding the reason for valve explant.Post production residual risk is communicated in the product's labeling and instruction for use (ifu).The ifu states it is possible that complications of prosthetic heart valves could lead to reoperation or explantation.
Event or Problem Description
According to the available information, the patient received on-x mitral heart valve with standard sewing ring - 27/29mm in 2010.The valve was explanted due to unknown reasons in (b)(6) 2014 and the patient received on-x mitral heart valve with conform-x sewing ring - 25/33mm.Multiple attempts were made to obtain additional information, including the reason for reoperation, operative notes, and patient comorbidites; however, all attempts were unsuccessful.

• Brand Name: ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 27/29MM
• Common Device Name: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• MDR Report Key: 5995294
• Report Number: 1649833-2016-00021
• Device Sequence Number: 569942
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 00851788001280
• 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 Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2016

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: Physician
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 10/03/2016
• 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: 52 YR