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

Model Number	4DM-30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, a memo4d ring size 30 was attempted to be implanted.After de-clamp, regurgitation did not stop.As such, the device was explanted on the same day.No further information is available at this time.
Additional Manufacturer Narrative
H3 other text : unknown disposition.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the annuloplasty ring 4dm-30 has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Since limited information is available, the definitive root cause of the reported event cannot be established at this time.However, from the document review performed, no manufacturing deficiencies were noted.Should further information be received in the future, a follow up report will be provided.
Event or Problem Description
On (b)(6) 2023, a memo4d ring size 30 was attempted to be implanted.After de-clamp, regurgitation did not stop.As such, the device was explanted on the same day.The manufacturer was informed that no further information will be provided.

• Brand Name: MEMO 4D ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercellli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 18096875
• Report Number: 3005687633-2023-00127
• Device Sequence Number: 17570092
• Product Code: KRH
• UDI-Device Identifier: 08022057015433
• UDI-Public: (01)08022057015433(240)4DM-30(17)271204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 12/13/2023

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 Model Number: 4DM-30
• Device Catalogue Number: 4DM-30
• Was Device Available for Evaluation?: No
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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 Sex: Unknown