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

Model Number	MRCS26
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Mitral Insufficiency (1963); No Information (3190)
Date of Event	10/26/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 8121190
• Report Number: 3005687633-2018-00224
• Device Sequence Number: 211536
• Product Code: KRH
• UDI-Device Identifier: 08022057015068
• UDI-Public: (01)08022057015068(240)ICV1331(17)210706
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K071327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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 Expiration Date: 07/06/2021
• Device Model Number: MRCS26
• Device Catalogue Number: ICV1331
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR