MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ AUSTIN ONX MITRAL STANDARD 25; HEART-VALVE, MECHANICAL

Model Number ONXM-25

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

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/04/2021

Event Type  Injury  

Event Description

According to initial reports, "case was a third time redo on a very small patient.She implanted to mitral valve into a very small annulus, but it fit.Came off bypass and one of the leaflets opened and wouldn't close.Went back on bypass and took the valve out.Resect more of the mitral structures and rinsed and inspected valve.Both leaflets functioned, so she re-implanted it.After coming off bypass one leaflet opened and didn't close again.She removed the valve and implanted a bioprosthetic valve.".

• Brand Name: ONX MITRAL STANDARD 25
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC. ¿ AUSTIN; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts bvld; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 11401636
• MDR Text Key: 234408147
• Report Number: 1649833-2021-00008
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/05/2021
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention