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

Model Number	CNA21
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device explant not reported.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8182726
• Report Number: 3004478276-2018-00369
• Device Sequence Number: 2024471
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)230430
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 01/28/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/28/2019; 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 62 YR