MAUDE Adverse Event Report: CRYOLIFE, INC. ON-X AORTIC HEART VALVE W/STANDARD SEWING RING & EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXAE-21

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

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 08/10/2022

Event Type  malfunction  

Event Description

Patient had an aortic valve replacement with usage of a mechanical valve.Surgery without complications.Patient died several days later at home.

• Brand Name: ON-X AORTIC HEART VALVE W/STANDARD SEWING RING & EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd nw; kennesaw GA 30144
• MDR Report Key: 15334510
• MDR Text Key: 299052559
• Report Number: 15334510
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ONXAE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Female
• Patient Weight: 100 KG