MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

Model Number MRCS26

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Insufficiency (1963); No Information (3190)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

Due to the limited information on the patient's outcome and the link with the device, the event is being reported in a conservative manner.The manufacturer is following up to obtain further information on the event.Device location not presently known.

Event Description

The manufacturer was informed that a memo3d rechord was implanted and explanted intra-operatively on (b)(6) 2018.No other information is currently available.

Event Description

On (b)(6) 2018, a mitral repair with a memo3d rechord was attempted.However, after the ring was implanted, it was observed that the patient's mitral valve was still incompetent.Therefore, the surgeon decided to concert the repair to a full mitral valve replacement.The patient did well after surgery.

Manufacturer Narrative

Based on the information reported, the event is attributable to the patient's anatomy.Moreover, the patient is doing well after the surgery.As such, further investigation is not warranted at this time.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Type of Device: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8121190
• MDR Text Key: 128936444
• Report Number: 3005687633-2018-00224
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 08022057015068
• UDI-Public: (01)08022057015068(240)ICV1331(17)210706
• Combination Product (y/n): N
• PMA/PMN Number: K071327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2021
• Device Model Number: MRCS26
• Device Catalogue Number: ICV1331
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR