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

Model Number TBD

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

Patient Problem Mitral Valve Stenosis (1965)

Event Type  Injury  

Manufacturer Narrative

H3 other text : unknown disposition.

Event Description

The manufacturer was informed that a memo 3d (unknown size and serial) was implanted in the patient in 2016.Reportedly, during the follow-up examination, mitral stenosis was noted.During the re-operation, excessive pannus was noted, the ring was explanted, and mvp was conducted only using the suture.The outcome of the patient is good.It was reported that the explanted ring was clean without any breakage.

Event Description

The manufacturer was informed that a memo 3d (unknown size and serial) was implanted in the patient in 2016.Reportedly, during the follow-up examination, mitral stenosis was noted.During the re-operation, excessive pannus was noted, the ring was explanted, and mvp was conducted only using the suture.The outcome of the patient is good.It was reported that the explanted ring was clean without any breakage.Based on the comment received from medical professional, the explanted memo3d was not defective.The manufacturer was informed that no further information will be provided.

Manufacturer Narrative

Updated fields: b4, b5, g3, g6, h2, h6.Since serial number is not available and the device was not returned to the manufacturer, no further investigation on the device can be performed at this time.Since further investigation on the device could not be performed, the definitive root cause of the reported event cannot be established at this time.However, based on the medical comment received, the explanted memo3d was not defective.It is possible that the patient condition and clinical factors has contributed to the cause of the reported event but since limited information is available in this regard, this cannot ultimately be confirmed.Should further information be received in the future, a follow up report will be provided.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Type of Device: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer (Section G): CORCYM S.R.L.; strada crescentino; saluggia, vc
• Manufacturer Contact: laura mannino ; 5005 north fraser way; burnaby, bc
• MDR Report Key: 17569424
• MDR Text Key: 321406091
• Report Number: 3005687633-2023-00121
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 09/19/2023

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: TBD
• Device Catalogue Number: TBD
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 83 KG