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

Model Number	PVS25
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of an endocarditis event involving a perceval plus valve size l.Based on the information available, a perceval plus valve size l was implanted in a patient on the patient on (b)(6) 2021 through mics approach, type 0.Reportedly, one of the valve leaflets was torn and the surgeon suggested that it might be due to endocarditis.No functionality problem was noted last june.Reportedly, the valve was explanted on (b)(6) 2026.
Additional Manufacturer Narrative
Manufacturer is retrieving and reviewing the production record of the device.A follow up report will be provided upon completion of this review and/or receipt of any further relevant information.
Additional Manufacturer Narrative
Updated sections a2, a3a, b3, b4, b7, g3, g6, h2, h6 corrected sections: b5 (valve model), d4 (valve model).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.Based on the medical judgement available, the event occurred due to endocarditis which occurred more than 4.5 years postop avr.As reported in scientific literature, after 2 months of surgery endocarditis occurs due to late-onset nosocomial infection or due to a community-acquired infection.As such, there is no reason to suggest that the event is attributed to the device.
Event or Problem Description
The manufacturer was notified of an endocarditis event involving a perceval valve.The following provides a summary of all information currently available.A perceval valve pvs25/l was implanted in a patient on (b)(6) 2021 through mics approach, type 0.One of the valve leaflets was torn and the surgeon indicated that it is due to endocarditis.The valve was eventually explanted on (b)(6) 2026.No other further information is available at this time.

• 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: 24904074
• Report Number: 3004478276-2026-00133
• Device Sequence Number: 15722490
• Product Code: LWR
• UDI-Device Identifier: 00896208000436
• UDI-Public: (01)00896208000436(240)ICV1210(17)220414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• 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): 05/28/2026

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: 04/14/2022
• Device Model Number: PVS25
• Device Catalogue Number: PVS25
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2019
• 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: Male