MAUDE Adverse Event Report: CORCYM CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE

Model Number	PVS21
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer was informed that a perceval valve pvs21 was implanted on (b)(6) 2022.Reportedly, since svd was found, the valve was explanted and replaced by avalus 19mm on (b)(6) 2024.No further information is available at this time.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6.The device has been returned to the manufacturer and investigation is ongoing.Furthermore, manufacturer is retrieving and reviewing the manufacturing documents.A follow up report will be provided upon completion of investigation on the device and/or review of manufacturing records.
Additional Manufacturer Narrative
Examination of the valve revealed a deformed prosthesis due to intrinsic and vegetating calcifications in all leaflets.There was pannus overgrowth on the inflow skirt of the valve.The stent and the skirt were covered by fibrous pannus that on the inflow side protruded 2-4mm into the lumen, narrowing the annulus, and contributes to stenosis.The tops of all posts were covered by fibrous pannus that grew on the free edges of leaflets also so contributes to stenosis.The pericardium of leaflet c was thicker than normal due to calcification.Calcified thrombus depositions were visible on almost all inflow surfaces.The free edge of leaflet b was outflow bent near both posts due to fibrous pannus and so caused a low degree of insufficiency.Leaflets a and c were almost stiff because of intrinsic and vegetating calcifications.Intrinsic and vegetating calcifications were also visible on leaflet b.Scars and/or mesothelial delaminations were visible where intrinsic calcifications became extrinsic.A surgical stitch was detected inside the crown components.On leaflet a, yellowish areas due to calcifications were detected.On leaflet c, yellowish areas due to calcifications were detected.On the belly there was a hole.X-rays of the subject valve showed large intrinsic calcifications in all leaflets.Histological analyses were performed on samples taken from leaflets b and c.In leaflets b and c, alizarin red s stain showed that the pericardium was slightly thicker than normal because of large intrinsic calcifications (red arrows).In leaflets b and c, hematoxylin and eosin stain showed that the collagen bundles were disrupted, defibrated and homogenated.Fibrous pannus depositions were visible on the mesothelial surface of leaflet a and on both surfaces of leaflet c.Pericardial delaminations were detected on leaflets b and c.Bacteria were not detected with the gram stain.This perceval s valve was explanted after 2 years and 8 months due to structural valve deterioration.Leaflets calcification, detected with visual, x-ray and histological analyses, caused stiffening and led to progressive valve stenosis.Pannus tissue overgrowth into the inflow lumen also contributed to valve stenosis.Aortic insufficiency likely resulted from 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).It is possible that the patient¿s clinical conditions and risk factors may have contributed to the structural valve deterioration observed in this perceval s valve but this cannot ultimately be confirmed due to limited information available.It should be noted that structural valve deterioration is listed as a potential adverse event in the perceval s.The event is, therefore, a known inherent risk of the device.

• Brand Name: PERCEVAL SUTURELESS AORTIC 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: 21108818
• Report Number: 3004478276-2025-00112
• Device Sequence Number: 15647084
• Product Code: LWR
• UDI-Device Identifier: 00896208000412
• UDI-Public: (01)00896208000412(240)ICV1208(17)241103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 03/09/2025

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: 11/03/2024
• Device Model Number: PVS21
• Device Catalogue Number: ICV1208
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 02/07/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/06/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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: 79 YR
• Patient Sex: Female