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

Model Number	4DM-30
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complete manufacturing and material records review for the memo 4d, model # 4dm-30, serial # (b)(6) was performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Manufacturer is following up to retrieve further information regarding this event.A follow up report will be provided upon receipt of any further information.H3 other text : wasted by site.
Event or Problem Description
The manufacturer became aware of the following event through patient tracking department.Reportedly, on (b)(6) 2023, a memo 4d annuloplasty ring size 30 was implanted and explanted intra-operatively.No further information is available at this time and no indication of device malfunction nor serious injury on the patient has been received from the site.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the memo 4d- 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.From the document review performed, no manufacturing deficiencies were noted.Based on manufacturer's clinical experience, an intra-operative explant of a mitral ring followed by total mitral valve replacement is attributable to patient factors that precluded adequate repair with a ring.As such, the event is not related to a deficiency of the device which was confirmed by information received (i.E., there was no problem with the ring).
Event or Problem Description
The manufacturer became aware of the following event through patient tracking department.Reportedly, on (b)(6) 2023, a memo 4d annuloplasty ring size 30 was implanted and explanted intra-operatively.Based on the further information received, the ring was explanted due to the failed repair and was replaced with a valve.Reportedly, there was no problem with annuloplasty ring.

• 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: 17932271
• Report Number: 3005687633-2023-00125
• Device Sequence Number: 6401642
• Product Code: KRH
• UDI-Device Identifier: 08022057015433
• UDI-Public: (01)08022057015433(240)4DM-30(17)270202
• 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): 11/21/2023

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: 09/15/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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: 78 YR
• Patient Sex: Female