MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

Model Number	MRCS30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacture was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a memo 3d rechord #30 valve was implanted and explanted on the same day on (b)(6) 2021.No further information about any device malfunction, patient outcome or device finally implanted was received from the site regarding this event.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 12551106
• Report Number: 3019892983-2021-01013
• Device Sequence Number: 4220887
• Product Code: KRH
• UDI-Device Identifier: 08022057015082
• UDI-Public: (01)08022057015082(240)ICV1333(17)231106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 09/29/2021
• 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: 11/06/2023
• Device Model Number: MRCS30
• Device Catalogue Number: ICV1333
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2021
• Device Age: 3 YR
• 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: 09/29/2021
• 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: 18 YR