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

Model Number	4DM-32
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a memo 4d size 32 valve was implanted and explanted on the same day on (b)(6) 2021.No allegation of a device malfunction or serious adverse event for the patient 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.Since the device was not returned to the manufacturer at the time of the event (unknown disposition) no further investigation is possible at this time.Based on the information available, it is not possible to establish a root cause for the reported event.However, from the document review performed, no manufacturing deficiencies were identified.The manufacturer is following up with the site to retrieve more information about this event.Should any further information be received, a follow up report will be provided as deemed applicable.
Event or Problem Description
The manufacturer was informed of the event through the patient tracking department.Based on the information reported in the patient implant form, a memo 4d size 32 valve was implanted and explanted on the same day on (b)(6) 2021.No allegation of a device malfunction or serious adverse event for the patient was received from the site regarding this event.Per additional information received, the physician confirmed that no device malfunctions were identified.The reason for the intraoperative explant of the 4dm-32 ring was due to a failed repair.As reported in the operative note received, after the implant of the ring, the mitral valve was tested.The mitral regurgitation had improved significantly, however there was still mild mitral regurgitation.In view of the patients age and the pathology of the valve this was felt to be not acceptable.The device was ultimately replaced with a competitor's valve (33mm st jude mechanical valve) after resection of the anterior leaflet and of the heavily calcified thickened chordal mass at each commissure.The posterior leaflet was preserved.The patient had a good outcome.
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.Since the device is reportedly not available for return, no further investigation is possible at this time.Based on the information available, the memo 4d ring was explanted due to an unsuccessful repair of the mitral valve; a full replacement was consequently performed.The intra-operative explant of a mitral ring followed by total mitral valve replacement is attributable to patient factors that precluded adequate repair with an annuloplasty ring, as reported in the operational note received (i.E.''in view of the patients age and the pathology of the valve this was felt to be not acceptable'').Furthermore, no device malfunctions occurred as informed by the physician.As such, the event is not related to a deficiency of the device.Given that the patient had a good outcome after the procedure, there is no indication that an adverse event has occurred.

• 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: francesca crovato ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 13311888
• Report Number: 3005687633-2022-00097
• Device Sequence Number: 17385767
• Product Code: KRH
• UDI-Device Identifier: 08022057015440
• UDI-Public: (01)08022057015440(240)4DM-32(17)260311
• 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: 2021
• Device Explanted Year: 2021
• 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): 02/22/2022

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: 03/11/2026
• Device Model Number: 4DM-32
• Device Catalogue Number: 4DM-32
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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: 56 YR
• Patient Sex: Male