MAUDE Adverse Event Report: Corcym S.r.l. Memo 4D Annuloplasty Ring; Mitral Annuloplasty Ring

Model Number	4DM-34
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of an intraoperative explant involving a memo 4d annuloplasty repair ring.Based on the information available to the manufacturer from the patient tracking audit.On (b)(6) 2024, a memo 4d annuloplasty repair ring size 34 was implanted and explanted during the same day and the device was reported as "wasted".No further details about the event, device or patient have been received from the site at this time.
Additional Manufacturer Narrative
Manufacturer will submit follow-up report upon completion of document review and/or availability of new information from the healthcare facility.

• 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 13040 ; IT 13040
• Manufacturer (Section G): Corcym S.r.l.; via per crescentino sn; saluggia, vc 13040
• Manufacturer Contact: laura mannino ; via per crescentino sn; saluggia, vc 13040
• MDR Report Key: 50500692
• Report Number: 3005687633-2026-00113
• Device Sequence Number: 9460161
• Product Code: KRH
• UDI-Device Identifier: 08022057015457
• UDI-Public: (01)08022057015457(240)4DM-34(17)281007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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