MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number	ONXANE-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, "i received a call today from a surgeon at [hospital] stating a patient is having hemolysis and he (the patient) thinks it¿s because of the on-x heart valve." additional information was provided: 1.Product code and serial number of the valve? prosthesis installed: item: valve, implant sterility checked (y/n): yes, sterility expiration date: jan 17, 2024, rn verifier: [xxx], vendor: on-x life technologies, inc., model: onxane, lot number: none, serial number: (b)(4), sterile resp: manufacturer, size: 21mm.2.Initial date of surgery? (b)(6) 2018.3.Reason for implantation of valve? severe aortic insufficiency.4.Date the hemolysis was diagnosed? unknown.5.Action taken by surgeon to address the hemolysis? none.6.How is the patient currently doing? still getting periodic iron transfusions.7.Are operative notes available for review? no additional information forthcoming.

• Brand Name: ON-X AORTIC VALVE UNKNOWN CONFIGURATION
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 12307950
• Report Number: 1649833-2021-00026
• Device Sequence Number: 12012527
• Product Code: LWQ
• UDI-Device Identifier: 00851788001655
• UDI-Public: 00851788001655
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 01/17/2024
• Device Model Number: ONXANE-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other