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

Model Number	4DM-34
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/03/2023
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.No indication of ring explant.Valve in ring will be performed.
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.
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.Based on the further information received, the ring was explanted and replaced by a st jude¿s mitral valve on (b)(6) 2023.Reportedly, there was no malfunction of the 4dm ring.The leak was not caused by the mitral repair procedure and was due to rapture identified at different area.Furthermore, patient¿s outcome is good.
Additional Manufacturer Narrative
Based on the medical judgement received, there was no device malfunction of the device and cause of the event was not related to the device.Furthermore, from the document review performed, no manufacturing deficiencies were noted.As such, the cause of the event was traced to the non-device related factors.H3 other text: device was discarded at the hospital.

• Brand Name: MEMO 4D ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16623815
• Report Number: 3005687633-2023-00105
• Device Sequence Number: 4511624
• 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
• PMA/510(K) Number: K180411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/19/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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: 75 YR
• Patient Sex: Male