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

Model Number	4DM-38
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/10/2023
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 available, memo 4d size 38 was implanted in mitral position due to leaflet prolapse, insufficiency, chordal fusion, and chordal rupture / flail on (b)(6) 2023 through mini thoracotomy.Patient also received a sovering band size 34 in tricuspid position on the same day.Reportedly, annular dilation was found.Based on the information available, patient was presented with myocardial infarction and occlusion of the circumflex artery on the same day.Reportedly, the action taken was cabg of the occluded circumflex artery, and transfusion.Further exams and tests were also performed.The outcome of the event was reported as recovered/resolved.Based on the information in the database, patient has a history of persistent arrhythmia, systemic hypertension, dyslipidemia, and is assessed as nyha class i.Based on the site's assessment, cause of the event was possibly related to memo 4d, initial implant procedure, primary condition being treated and definitely related to concomitant medication.
Additional Manufacturer Narrative
Device remains implanted.
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.
Additional Manufacturer Narrative
Since further investigation on the device could not be performed, the definitive root cause of the reported event cannot be established at this time.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.

• 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: 16685648
• Report Number: 3005687633-2023-00107
• Device Sequence Number: 17965210
• Product Code: KRH
• UDI-Device Identifier: 08022057015471
• UDI-Public: (01)08022057015471(240)4DM-38(17)270512
• 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
• 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,Followup
• Report Date (Section B): 06/07/2023

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-38
• Device Catalogue Number: 4DM-38
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 06/07/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/18/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 86 KG