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

Model Number ONXM-25

Device Problem Device Handling Problem (3265)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2021

Event Type  Injury  

Event Description

According to initial reports, "on x mitral 25 was explanted and a different onx m 25 was successfully implanted.Surgeon stated that the original valve had an immobile leaflet." additional information received."the patient did suffer some adverse events ¿ the patient had to go back on bypass and re-arrest the heart.This added pump time.When the first valve was seated, the white holder did not want to release appropriately.The patient is currently recovering as expected in the cvicu." the valve will be returned.The holder will not.

• 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 blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12657613
• MDR Text Key: 277177119
• Report Number: 1649833-2021-00038
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 851788001273
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/21/2021
• Date Manufacturer Received: 09/21/2021
• 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