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

Model Number	4DM-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturer received the information from device tracking department.A memo 4d annuloplasty mitral repair ring 4dm-30 was implanted in a patient on (b)(6) 2021.A mitral valve replacement procedure was performed on (b)(6) 2025 due to the mitral regurgitation.No other information has yet been received from the site.
Additional Manufacturer Narrative
Manufacturer retrieving and reviewing the production record of the device.A follow up report will be provided upon completion of this review.
Additional Manufacturer Narrative
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.Sine the device was not returned to the manufacturer, further investigation on the device could not be performed, however, based on the judgment received form the site, there was no malfunction with the device.Furthermore, no manufacturing deficiencies were noted from the document review.As such, the cause of the event is not related to the device.
Event or Problem Description
Manufacturer received the information from device tracking department.A memo 4d annuloplasty mitral repair ring 4dm-30 was implanted in a patient on (b)(6) 2021.A mitral valve replacement procedure was performed on (b)(6) 2025 due to the mitral regurgitation.Based on the information received from patient report, mitral valve repair performed in the right minimally invasive fashion with a 30mm ring annuloplasty with 2 sets of artificial gore-tex cords to the posterior mitral leaflet, which had suffered chordal rupture.The initial results looked good with no recurrent insufficiency or prolapse.Reportedly, over the last 6 to 12 months, patient has noted progressive symptoms of dyspnea on exertion and exercise intolerance while exercising.Patient does not have symptoms at rest or with activities of daily living.Transesophageal echocardiography demonstrated the ejection fraction to be 40 to 45% with moderate to severe recurrent eccentric mitral insufficiency that is anteriorly directed.As reported, the posterior leaflet looked to be retracted in the images so that the anterior leaflet was not making good contact.Patient's left atrium was severely dilated, which was the same at the time of initial surgery.Patient had a postoperative atrial fibrillation and had a pacemaker placed after the surgery as well as cardioversion.Patient has been maintained on eliquis and metoprolol.On echocardiography, mild enlargement of his aortic root and ascending aorta at 4.2 cm at the level of the sinus of valsalva was noted.Mitral valve replacement, left atrial maze procedure, and left atrial appendage exclusion were decided to be performed.Based on the information received from the site, no malfunction with the device was noted and redo mitral valve replacement was completed successfully.

• 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: 21997003
• Report Number: 3005687633-2025-00111
• Device Sequence Number: 15823820
• Product Code: KRH
• UDI-Device Identifier: 08022057015433
• UDI-Public: (01)08022057015433(240)4DM-30(17)260825
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/06/2025

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 Expiration Date: 08/25/2026
• Device Model Number: 4DM-30
• Device Catalogue Number: 4DM-30
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2021
• 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: 64 YR
• Patient Sex: Male