MAUDE Adverse Event Report: ON-X AORTIC VALVE UNKNOWN ON-X AORTIC VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Corneal Pannus (1447)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial information "report of pannus formation with on-x valve.Valve has been explanted.".

Manufacturer Narrative

According to initial information, "report of pannus formation by surgeon and explant of the valve.However additional information received indicated that the valve has not been explanted yet.A date for surgical intervention has not been determined.Based on the limited amount of information, a definitive case of pannus cannot be determined and it is unclear how the diagnosis of alleged pannus was made.It is also unclear when the valve was implanted or if there were any other comorbid conditions that may be pertinent.Pannus formation for the on-x aortic valve is rare as the valve protrudes, in part, into the annulus.But over time, there can be tissue overgrowth which can constrict the inflow area leading to stenosis.The instructions for use lists prosthesis pannus as a potential adverse event.Such complications may result in reoperation and/or explantation [ifu].No further action is required.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial information "report of pannus formation with on-x valve.Valve has been explanted.".

• Brand Name: ON-X AORTIC VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X AORTIC VALVE UNKNOWN; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 8651800
• MDR Text Key: 146425647
• Report Number: 1649833-2019-00032
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/13/2019
• Date Manufacturer Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention