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

Model Number	CNA19
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A crown valve size 19 was implanted in 2018.Reportedly, on (b)(6) 2023, the valve was explanted since aortic stenosis and aortic regurgitation due to svd were noted.Based on the information available, regent 19 was implanted instead as the replacement.There was no impact on the patient and outcome was good.The manufacturer was informed that no further information will be provided.
Additional Manufacturer Narrative
Device has been returned to the manufacturer and the investigation is ongoing.Furthermore, the manufacturer is retrieving and reviewing the manufacturing documents.A follow up report will be provided upon receipt of any further information and/or completion of investigation.
Additional Manufacturer Narrative
The manufacturing and material records for the crown prt aortic pericardial heart valve, model # cna19, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at corcym 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 valve has been returned to the manufacturer.All the leaflets were pliable.Reddish areas due to coagulated blood entrapment were present on some outflow surfaces.Whitish areas due to tissue alterations were detected on almost all outflow surfaces.The mesothelial surfaces of all leaflets were locally wrinkled.Mesothelial grooves were visible in all leaflets.On leaflet b, at post 3 there was a hole.Mesothelial delaminations were visible near post 2.On leaflet c, mesothelial delaminations were visible near post 1.X-rays of the subject valve showed a small intrinsic calcification in leaflet c.Histological analyses were performed on samples taken from leaflets a and c.In leaflet a, hematoxylin and eosin stain showed that the collagen bundles were disrupted, defibrated and homogenated.The pericardium of leaflet c was thicker than normal because the collagen bundles were disrupted, defibrated and homogenated.And because cholesterol clefts were detected.Fibrous pannus depositions were visible on both surfaces of leaflet a.Pericardial delaminations were detected on leaflets a and c.Bacteria were not detected with the gram stain.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 prt ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: CROWN PRT PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18250721
• Report Number: 3004478276-2023-00208
• Device Sequence Number: 20612058
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)200831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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: 08/31/2020
• Device Model Number: CNA19
• Device Catalogue Number: CNA19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 01/12/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/29/2023; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female