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

Model Number	SMD28
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of this event through the patient tracking department.Based on the information reported in the patient implant form, a memo 3d semirigid annuloplasty ring smd28 was implanted and explanted on (b)(6) 2021.No further information is presently available.No allegation of a device malfunction nor of a serious injury was received from the site regarding this event.
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.The manufacturer attempted to follow up on this event however, no further information has been received to date.Based on the information provided the root cause can be established.Based on the dhr there appears to be no issue with the valve, since the valve is not being returned no further investigation can be performed at this time, the case will be closed at this time.Should additional information be received at a later stage a follow up report will be provided.It should be noted that no allegation of a device malfunction and/or notification of a serious adverse event have been reported from the site.
Event or Problem Description
See initial report.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia 13040 ; IT 13040
• MDR Report Key: 11898159
• Report Number: 1718850-2021-01100
• Device Sequence Number: 16994210
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)250316
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/09/2021
• Report Date (Section F): 09/09/2021

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: 03/16/2025
• Device Model Number: SMD28
• Device Catalogue Number: ICV0968
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/09/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/13/2021
• 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: 78 YR
• Date Report Sent to FDA: 09/09/2021