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

Model Number	MRCS28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition presently unknown.
Event or Problem Description
On (b)(6) 2018 a memo 3d, mrcs28 mechanical mitral valve repair ring was involved in a procedure.The manufacturer was notified that the device was removed and not used.No additional information was provided.
Event or Problem Description
On (b)(6) 2018: a memo 3d, mrcs28 mechanical mitral valve repair ring was involved in a procedure.The manufacturer was notified that the device was removed and not used.Additional information was received from the site indicating that they attempted a difficult mitral repair with the memo 3d rechord but when they came off pump there remained a significant amount of mitral regurgitation.It was a myxomatus valve.They went back on pump and replaced the mitral valve.There was no incident with the memo 3d rechord.It was a repair attempt and then converted to a mitral valve replacement once the site evaluated the repair.
Additional Manufacturer Narrative
Additional information received on january 15, 2019.The following updated event summary has been included in section b5.On (b)(6) 2018 a memo 3d, mrcs28 mechanical mitral valve repair ring was involved in a procedure.The manufacturer was notified that the device was removed and not used.Additional information was received from the site indicating that they attempted a difficult mitral repair with the memo 3d rechord but when they came off pump there remained a significant amount of mitral regurgitation.It was a myxomatus valve.They went back on pump and replaced the mitral valve.There was no incident with the memo 3d rechord.It was a repair attempt and then converted to a mitral valve replacement once the site evaluated the repair.Based on the additional information received this event there was no device issue and the ring was not used do to a procedural change unrelated to the functionality of the device.Based on this the case is being closed with no further investigations.The root cause is deemed to be patient factors and the cause cannot be traced to the device.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RECHORD
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc
• MDR Report Key: 8224810
• Report Number: 3005687633-2019-00098
• Device Sequence Number: 218087
• Product Code: KRH
• UDI-Device Identifier: 08022057015075
• UDI-Public: (01)08022057015075(240)ICV1332(17)220529
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/15/2019

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: No Information
• Device Expiration Date: 05/29/2022
• Device Model Number: MRCS28
• Device Catalogue Number: ICV1332
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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: 59 YR