MAUDE Adverse Event Report: CORCYM S.R.L. MEMO 3D SEMIRIGID ANNULOPLASTY RING; MITRAL ANNULOPLASTY RING

Model Number SMD32

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2024

Event Type  Injury  

Event Description

The manufacturer was informed that on (b)(6) 2024, a patient with mitral valve insufficiency went under operation with memo 3d size 32.Reportedly, during the procedure, it was found that the ring was deformed and could not be used.As such, the ring was explanted, and another same model product was implanted instead to complete the surgery.Based on the further information received, patient/user was not affected, patient was stable through the surgery and was sent to icu after the procedure.No further information is available at this time.

Manufacturer Narrative

A complete manufacturing and material records review for the annuloplasty ring icv0970 has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.A follow up report will be provided upon receipt of the device and/or any additional information regarding the event.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 18727716
• MDR Text Key: 335808758
• Report Number: 3005687633-2024-00099
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071327
• 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
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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: 57 YR
• Patient Sex: Male