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

Model Number	ONXM-25
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 1649833-2021-00038
• Device Sequence Number: 4298751
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 851788001273
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2021

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 Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown