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	Mitral Valve Insufficiency/ Regurgitation (4451)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.
Event or Problem Description
The manufacturer received the following information through patient tracking department.Based on the information received, a memo4d annuloplasty ring size 34 was implanted in the patient on (b)(6) 2021.Reportedly, the patient was scheduled for a mitral valve in ring re-intervention procedure due to leakage.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.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 16623789
• Report Number: 3019892983-2023-01009
• Device Sequence Number: 4474414
• Product Code: KRH
• UDI-Device Identifier: 08022057015457
• UDI-Public: (01)08022057015457(240)4DM-34(17)260209
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2023
• Report Date (Section F): 03/01/2023

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: 02/09/2026
• 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
• Distributor Facility Aware Date: 03/01/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2023
• Date Device Manufactured: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male