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

Model Number ONXMC-25/33

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endocarditis (1834)

Event Date 02/04/2021

Event Type  Injury  

Event Description

According to the initial report, "received a mitral 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.(b)(6) 2020 sn#(b)(4) tricuspid position sn#(b)(4) mitral position.(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
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd.; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11738053
• MDR Text Key: 247762518
• Report Number: 1649833-2021-00014
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001303
• UDI-Public: 00851788001303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other