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

Model Number	4DM-28
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device already discarded by site.
Event or Problem Description
The manufacturer was notified of a case of memo 4d (4dm-28 ) ring dehiscence after 1 year of implant (doi: (b)(6) 2020, and doe: (b)(6) 2021).The patient was re-operated with good results.Based on the preliminary information received, the event appears to be related to a detachment of the sutures and not to a detachment of the fabric of the ring.The patient was already discharged from the hospital.The device is unavailable for return as it was already discarded by the site.The device was replaced with an edwards phisio ii size 26.
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 already discarded by the site, no further investigation is possible at this time.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 the reported dehiscence is related to a detachment of the sutures rather than a detachment of the fabric, a structural failure of the prosthesis is unlikely based on the information provided.Ultimately, given that no further investigation was possible and limited information on the event was provided, the root cause remains unknown at this time.

• 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: 12566061
• Report Number: 3005687633-2021-00158
• Device Sequence Number: 1335536
• Product Code: KRH
• UDI-Device Identifier: 08022057015426
• UDI-Public: (01)08022057015426(240)4DM-28(17)240826(11)190828
• 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 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): 11/09/2021

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: 08/26/2024
• Device Model Number: 4DM-28
• Device Catalogue Number: 4DM-28
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• 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: Male