MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL STANDARD 27/29; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

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

Patient Problems No Code Available (3191); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the initial report received 22-jan-2021 from cryolife representative, sm, "wexner had a defective on-x." this investigation will be relegated to onxm-27/29, sn (b)(4).Additional information was provided by cryolife representative, "(b)(6)-year-old female had a 27/29 on-x mitral implanted.Leaflet was not fully closing once heart was filled.Surgeon removed a pledget to see if this helped.The leaflet was not fully closing; surgeon removed and replaced with tissue valve.Patient was placed back on pump 2x before valve was removed and replaced with tissue valve.".

• Brand Name: ONX MITRAL STANDARD 27/29
• 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: 11365023
• MDR Text Key: 233065707
• Report Number: 1649833-2021-00005
• Device Sequence Number: 1
• Product Code: LWQ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other