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

Model Number	CNA21
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna21, s/n # (b)(4), 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.The manufacturer is following up to retrieve additional information on this event, device problem and patient impact.An update will be provided based on additional information received.
Event or Problem Description
The manufacturer was informed on an early valve failure of a crown cna21.No further information has been provided on implant duration time, valve explant, expected therapy or patient impact.
Additional Manufacturer Narrative
Since the device was not returned no further investigation is possible at this time.Based on the available information, it is not possible to draw a definitive root cause for the reported event.However, from the document review performed, no manufacturing deficits were identified.From the pathology examination received from the site, it is reported that the device showed vegetating calcifications.As reported in the scientific literature, structural valve deterioration is the major cause of failure of bioprosthetic heart valves and the principal underlying pathologic process is cuspal calcification.Calcification can also cause stenosis due to cuspal stiffening.Calcific deposits are usually localized to cuspal tissue (intrinsic calcification).It is possible that the patient¿s clinical history and risk factors may have contributed to the structural valve deterioration observed in this crown valve.However, little clinical history was provided and a definitive root cause cannot be stated at this time.It should be noted that structural valve deterioration is listed as a possible adverse event in the crown ifu.The event is, therefore, a known inherent risk of the device.H3 other text: device still with site pathology department.
Event or Problem Description
On (b)(6) 2017, a crown valve cna21 was implanted in aortic position.The patient had an early heart valve failure and underwent a re-do surgery on (b)(6) 2021.As reported, the valve had stiffening of the leaflets with retraction that resulted in functional aortic stenosis and insufficiency simultaneously.The patient ultimately received a edwards inspiris 21 was discharged on (b)(6) 2021.The explanted crown valve was sent to the pathology department.The results of the pathology examination showed calcified vegetations.

• 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: 11325790
• Report Number: 3004478276-2021-00125
• Device Sequence Number: 16828533
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)190831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 08/31/2019
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 05/08/2021
• 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: Other; Required Intervention
• Patient Age: 62 YR