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

Model Number	CNA21
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed that on (b)(6) 2018, a crown prt heart valve size 21 was implanted in a patient.Reportedly, the valve was explanted and replaced with perceval s valve size 21 on (b)(6) 2023 since svd was noted.Based on the further information received, there was overgrowth of pannus and calcification on the valve.As such, the valve was not functioning properly.As reported, outcome was good.No further information will be provided.
Additional Manufacturer Narrative
The valve was returned to the manufacturer.The pericardium of leaflets a and b was thicker than normal due to calcifications while the pericardium of leaflet c was thicker than normal near post 3 due to pericardial degeneration.Pericardial delaminations were detected in all leaflets.The free edge of leaflet c was outflow bent at the centre and so contributed to insufficiency.Small thrombus depositions were visible on some inflow surfaces.Reddish areas due to coagulated blood entrapment were present on all surfaces.Leaflets a and b were almost stiff because of intrinsic and vegetating calcifications.Intrinsic and vegetating calcifications were also visible on leaflet c.Scars and/or mesothelial delaminations were visible where intrinsic calcifications became extrinsic.Yellowish areas due to calcifications were detected on both prosthetic sides.Mesothelial delaminations were visible on all leaflets.On leaflet a, a 3 mm long tear was present at post 1.On leaflet b, a 5 mm long tear was present at post 2.On leaflet c, holes were detected at both posts.Mesothelial grooves and whitish areas were visible.X-rays of the subject valve showed large intrinsic calcifications in leaflets a and b.Small intrinsic calcifications were also present inside leaflet c.Histological analyses were performed on samples taken from leaflets a and c.In leaflet a, alizarin red s stain showed that the pericardium was thicker than normal because of large intrinsic calcifications.In leaflet c, hematoxylin and eosin stain showed that the pericardium was thicker than normal because the collagen bundles were disrupted, defibrated and homogenated; because the collagen bundles showed a bubbly aspect and because cholesterol clefts were detected.The collagen bundles of leaflet a were disrupted, defibrated and homogenated.Red blood cells were visible on leaflets a and c.A thrombus deposition was visible on the mediastinic surface of leaflet a.Pericardial delaminations were detected on leaflets a and c.Degenerated inflammatory cells were present in leaflet b.Bacteria were not detected with the gram stain.Based on the analysis performed, leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Aortic insufficiency likely resulted from leaflets tears and inadequate leaflet coaptation caused by calcification of the leaflets.There was no evidence of endocarditis in the returned valve.As reported in the scientific literature, structural dysfunction 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).Histological analysis showed the presence of small lipid infiltration (cholesterol clefts) in the pericardial tissue.This lipid infiltration, as supported from the scientific literature, may contribute to localized leaflet stiffness, and if associated with a degeneration of collagen fibers, as detected in the samples from this valve, may also lead to leaflet tearing.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, since little clinical history was provided, the definitive root cause of the reported event cannot be established.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: 17997230
• Report Number: 3004478276-2023-00187
• Device Sequence Number: 20463065
• Product Code: LWR
• UDI-Device Identifier: 00896208000511
• UDI-Public: (01)00896208000511(240)CNA21(17)210630
• 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 Implanted Year: 2018
• 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
• Report Date (Section B): 11/17/2023

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: 06/30/2021
• Device Model Number: CNA21
• Device Catalogue Number: CNA21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2018
• 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: 75 YR
• Patient Sex: Female