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

Model Number 4DM-30

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 325628514
• Report Number: 3005687633-2023-00125
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015433
• UDI-Public: (01)08022057015433(240)4DM-30(17)270202
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female