MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 4D ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number	4DM-34
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a memo4d annuloplasty repair ring 4dm-34 was implanted in the patient.After de-clamped, regurgitation was noted, the device was explanted, and another similar ring memo 4dm-34 was implanted instead.No further information is available at this time.

• Brand Name: MEMO 4D ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• 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: 21649656
• Report Number: 3005687633-2025-00104
• Device Sequence Number: 7480167
• Product Code: KRH
• UDI-Device Identifier: 08022057015457
• UDI-Public: (01)08022057015457(240)4DM-34(17)290722
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180411
• 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): 06/12/2026

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 Model Number: 4DM-34
• Device Catalogue Number: 4DM-34
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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 Sex: Unknown