MAUDE Adverse Event Report: CORCYM S.R.L. CARBOMEDICS REDUCED AORTIC HEART VALVE; MECHANICAL HEART VALVE PROSTHESIS

Model Number	R5-029
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated sections b4, b5, d9, g3, g6, h2, 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.Based on the limited information available, the definitive root cause of the reported event cannot be established at this time.However, from the document review, no manufacturing deficiencies were noted.Furthermore, based on the information received from the site, there was no malfunction with the device.As such, the cause of the event can be related to non-device related factors.
Event or Problem Description
Manufacturer was informed through device tracking about an intra operative explant of a carbomedics reduced aortic valve r5-029 on (b)(6) 2025.Further information confirmed that valve was explanted intraoperatively.The valve was explanted as the patient underwent a heart transplant instead.No device malfunction was identified.Patient recovering well following heart transplant.
Event or Problem Description
Manufacturer was informed through device tracking about an intra operative explant of a carbomedics reduced aortic valve r5-029 on (b)(6) 2025.No information is available at this time.
Additional Manufacturer Narrative
Manufacturing is retrieving further information from healthcare facility and performing review of manufacturing documents; will submit follow-up report upon availability of new, relevant details.

• Brand Name: CARBOMEDICS REDUCED AORTIC HEART VALVE
• Common Device Name: MECHANICAL HEART VALVE PROSTHESIS
• Manufacturer (Section D): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; via per crescentino sn; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 23998687
• Report Number: 3005687633-2026-00096
• Device Sequence Number: 16051932
• Product Code: LWQ
• UDI-Device Identifier: 08022057012814
• UDI-Public: (01)08022057012814(240)R5-029(17)230915
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P900060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 02/18/2026

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: 09/15/2023
• Device Model Number: R5-029
• Device Catalogue Number: R5-029
• Was Device Available for Evaluation?: No
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2018
• 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: 67 YR
• Patient Sex: Unknown