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

Model Number	4DM-28
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was notified of a case of memo 4d (4dm-28 ) ring dehiscence after 1 year of implant (doi: (b)(6) 2020, and doe: (b)(6) 2021).The patient was re-operated with good results.Based on the preliminary information received, the event appears to be related to a detachment of the sutures and not to a detachment of the fabric of the ring.The patient was already discharged from the hospital.The device is unavailable for return as it was already discarded by the site.The device was replaced with an edwards phisio ii size 26.

• 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: 12566059
• Report Number: 3019892983-2021-01012
• Device Sequence Number: 13806797
• Product Code: KRH
• UDI-Device Identifier: 08022057015426
• UDI-Public: (01)08022057015426(240)4DM-28(17)240826(11)190828
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2021
• Report Date (Section F): 09/02/2021

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: 08/26/2024
• Device Model Number: 4DM-28
• Device Catalogue Number: 4DM-28
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2021
• 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