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

Model Number	CNA19
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	06/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer is following up for additional information and awaiting the return of the explanted valve.A follow-up report will be submitted upon availability of new, relevant details.
Event or Problem Description
The manufacturer was notified of an early explant involving a crown prt biological aortic heart valve (unknown size and serial #) which was implanted in a juvenile patient.As reported, the prosthesis was explanted after about 12 months due to aortic stenosis.According to the information received, the valve was fully calcified.This prosthesis was replaced with a carbomedics standard mechanical aortic valve size 21.No further information has been provided at this time and the explanted valve will be returned for investigation.
Event or Problem Description
The manufacturer was notified of an early explant involving a crown prt biological aortic heart valve which was implanted in a juvenile patient.As reported, the prosthesis was explanted after about 12 months due to aortic stenosis.According to the information received, the valve was fully calcified.As further reported, postoperative anticoagulation was administered for 3 months (warfarin, inr ~2.0), then discontinued.The patient presented 10 months after implant with dyspnoea and chest pain due to severe aortic stenosis and bilateral pleural effusion.The initial treatment included medical therapy and bilateral pleural drainage.Reportedly, the device was eventually explanted and replaced with a carbomedics standard valve size 21mm.Aortic root enlargement (yang procedure) was performed during the re-do surgery.Intraoperative findings showed that the explanted valve was severely calcified with pannus formation and multiple calcific nodules.Valve leaflets were rigid and completely non-elastic.Based on the information received, lvef improved from 25% to 50% on postoperative day 1, and to 60% by day 20.
Additional Manufacturer Narrative
Corrected sections: a3a, h8.Updated sections: b4, b5, d4, g3, g6, h2, h4, h6.The manufacturing and material records for the device involved in this event, as they pertain to the reported issue, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this prosthesis satisfied all required material, visual, and performance standards at the time of manufacture and release.Additional information was received as indicated in section b5.A follow-up report will be submitted upon receipt of the device and completion of its investigation.
Additional Manufacturer Narrative
Updated sections b4, d9, g3, g6, h2, h3, h6, h11.The returned valve was received in the explant kit¿s plastic jar filled with unknown liquid but in good storage condition.Overall, the returned prosthesis showed extensive calcification.Following decontamination, visual inspection of the valve revealed stiff leaflets with calcific nodules at the commissures.No significant pannus formation was observed on the prosthesis.The prosthesis¿ cuff was found to be intact.X-ray imaging confirmed widespread calcification of the leaflets, with a pronounced presence at the commissures, involving both intrinsic and extrinsic deposits.Based on the results of the manufacturer's evaluation, it is reasonable to conclude that the reported degeneration should be attributed to the patient's young age at the time of implantation.This is consistent with the prosthesis¿ instructions for use (ifu), which caution that individuals aged 55 and under may have a higher tendency toward bioprosthetic valve calcification.It also aligns with current clinical guidelines and literature, which advise against the use of bioprosthetic valves in younger patients due to their increased risk of early structural deterioration.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): CORCYM CANADA CORP.; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 22370559
• Report Number: 3004478276-2025-00151
• Device Sequence Number: 17240605
• Product Code: LWR
• UDI-Device Identifier: 00896208000504
• UDI-Public: (01)00896208000504(240)CNA19(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: AJ
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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 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: 06/03/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 09/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/01/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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; Hospitalization
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 45 KG