MAUDE Adverse Event Report: CRYOLIFE ON-X PROSTHETIC HEART VALVE WITH CONFORM-X SEWING RING SIZE 25/33; MITRAL HEART-VALVE

Model Number 0000009257

Device Problems Component Falling (1105); Material Fragmentation (1261)

Patient Problem Failure to Anastomose (1028)

Event Date 04/06/2016

Event Type  malfunction  

Event Description

Dr.Had sewed in the valve and was unhappy with how the valve leaflets opened or how the valve was seated in the space.He asked to rotate the device with the provided rotator and while doing this the valve fell into several pieces.All pieces were removed and the valve was re pieced together on the sterile field to verify all pieces had been removed from the patient.

• Brand Name: ON-X PROSTHETIC HEART VALVE WITH CONFORM-X SEWING RING SIZE 25/33
• Type of Device: MITRAL HEART-VALVE
• Manufacturer (Section D): CRYOLIFE; 1655 roberts boulevard, nw; kennesaw GA 30144
• MDR Report Key: 5735116
• MDR Text Key: 47710910
• Report Number: 5735116
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2016,05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0000009257
• Device Catalogue Number: ONXMC-2533
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 77