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

Model Number	4DM-30
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Endocarditis (1834); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the following event through mantra study.Based on the information received, memo 4d annuloplasty ring, size 30 was implanted in the patient through mini-thoracotomy on (b)(6) 2023.Reportedly, mitral valve endocarditis, moderate to severe mi, and ring dehiscence was started on (b)(6) 2023.Based on the information available, medication was added, and mitral valve replacement was performed on (b)(6) 2023, and the issue was resolved.Patient has a history of systemic hypertension.Furthermore, infection due to wound healing disturbance was reported for the patient on (b)(6) 2023.
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.Sent to internal pathologist.
Event or Problem Description
The manufacturer was informed of the following event through mantra study.Based on the information received, memo 4d annuloplasty ring, size 30 was implanted in the patient through mini-thoracotomy on (b)(6) 2023.Mean mitral gradient at the time of discharge was 7mmhg.Reportedly, mitral valve endocarditis, moderate to severe mi, and ring dehiscence was started on (b)(6) 2023.Based on the information available, medication was added, and mitral valve replacement was performed on (b)(6) 2023, and the issue was resolved.Patient has a history of systemic hypertension.Furthermore, infection due to wound healing disturbance was reported for the patient on (b)(6)2023.Based on the pathology report received from the hospital, part of the sanded material was superimposed in methyl acrylate.Reportedly, consecutive sections were used for microscopic analysis and dna extraction.The fluorescence in situ hybridization (fish) was performed which led to detection of severely degraded microorganisms individually in the tissue with the nucleic-specific dye dapi.Reportedly, no active bacteria was detected in the fish.
Additional Manufacturer Narrative
Based on the information available, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified.Given that infection due to wound healing disturbance was reported for the patient, it is possible that this infection has been traveled in the patient and contributed to the reported endocarditis and ring dehiscence but since limited information is available and the device was not returned to the manufacturer for further investigation, this cannot be ultimately confirmed, and the cause of the reported event will remain unknown at this time.Should further information be received in the future, a follow up report 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, vercelli
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 16632775
• Report Number: 3005687633-2023-00106
• Device Sequence Number: 17929569
• Product Code: KRH
• UDI-Device Identifier: 08022057015433
• UDI-Public: (01)08022057015433(240)4DM-30(17)270313
• 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): 05/30/2023

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: 03/01/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 108 KG