MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number	ONXMC-25/33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial report, "received a tricuspid position mitral implant for a patient that already has one.One on (b)(6) 2020 one on (b)(6) 2021.Second implant sn (b)(4) onxmc 25/33".This investigation will be relegated to onxmc 25/33, sn (b)(4).Additional questions were answered by the user facility: why were the valves explanted? was there a deficiency? they were originally implanted (b)(6) 2020 with the expectation of termination of drug use.She returned (b)(6) 2021 with endocarditis and had to be explanted.On (b)(6) 2020 sn#(b)(4) tricuspid position sn#(b)(4) mitral position.On (b)(6) 2021 sn#(b)(4) tricuspid position sn#(b)(4) mitral position.Will the explanted valves be returned? we had no intent to return the valves due to the reason for explant.Why were the valves originally implanted? stated earlier.How is the patient post-operatively? poor condition.Many co-morbidities.Are operative notes available for us to review? i do not think that the notes are available for review.No additional information forthcoming.

• Brand Name: ONX MITRAL CONFORM 25/33
• 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: 11737680
• Report Number: 1649833-2021-00013
• Device Sequence Number: 3091795
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 01/30/2026
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other