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

Model Number 4DM-34

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/03/2023

Event Type  Injury  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 312098318
• Report Number: 3005687633-2023-00105
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015457
• UDI-Public: (01)08022057015457(240)4DM-34(17)260209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male