MAUDE Adverse Event Report: LIVANOVA CANADA CORP. CROWN PRT PERICARDIAL HEART VALVE; TISSUE HEART VALVE

Model Number CNA21

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Stenosis (2263)

Event Date 11/23/2018

Event Type  Injury  

Manufacturer Narrative

Device explant not reported.

Event Description

On (b)(6) 2018, a patient received an aortic valve replacement and a crown prt cna21 was implanted.A concomitant mitral valve replacement was performed and a pericarbon more 27mm mitral valve was implanted.2 months after the implant the patient's aortic valve became stenotic and the leaflets were reported to be thickened and non-moving.It was reported there was a large amount of vegetation around the annulus.The pericarbon valve was working fine.No additional information received.

Manufacturer Narrative

The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a crown prt aortic pericardial heart valve at the time of manufacture and release.

Manufacturer Narrative

The manufacturer received additional information on jan.29, 2019 identifying no further information would be provided by the site and the device was not available for return.Because the device was not returned and due to the limited event information and patient information the root cause of the reported stenosis and vegetation cannot be determined at this time.If the vegetation was resultant of an endocarditis is not likely the endocarditis was caused by any valve related factors based on the confirmation of the device sterilization in the device history record review.If an infective microorganism was present on the tissue valve before sterilization, it would be killed very easily by the manufacturers liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde, formaldehyde and alcohol, all of which are highly effective against infective microorganisms.The manufacturer has validated this liquid chemical sterilization process with spore forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.In addition, the sterile packaging solution used for shipment of mitroflow valves is a 4% formaldehyde solution; the valves remain in this extremely antimicrobial solution until they are opened during surgery.Therefore, it is not conceivable that an infective microorganism could survive on a valve exposed to the manufacturers sterilant, or the packaging solution.However, the root cause of the issue cannot be determined at this time.If the manufacturer receives additional information in the future the investigation will be reassessed.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8182726
• MDR Text Key: 131056399
• Report Number: 3004478276-2018-00369
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)230430
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR