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

Model Number	SMD30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2023
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.The manufacture was attempted to follow up with the site, but no further information has yet been provided despite multiple attempts of follow up.Based on the limited information available, it is not possible to establish a definitive root cause of the reported event.However, from the document review performed, no manufacturing deficiencies were identified.Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
The manufacture was informed of the following event through patient tracking department.Based on the information received, a patient received a memo 3d semirigid annuloplasty ring, smd30 in mitral position on (b)(6) 2022.Reportedly, the ring was eventually replaced with optiform prosthetic mitral heart valve size 29mm on (b)(6) 2023.No allegation of device malfunction nor serious injury on the patient has been received from the site.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 16963359
• Report Number: 3005687633-2023-00114
• Device Sequence Number: 17505883
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)230409
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 04/09/2023
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• 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: 54 YR
• Patient Sex: Female