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

Model Number	SMD32
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer narrative, the physician initially attempted to repair the mitral valve with the memo 3d.The repair was insufficient, and a mvr was performed.The physician reported that there was no problem with the memo 3d ring.Based on this narrative, the event is attributable to the operational context, as the original repair was not sufficient.This event has been deemed not device related, and no further investigation is required.Confirmation was received that no further information is available at this time.Device not available for return.
Event or Problem Description
A memo3d rechord was implanted and explanted on (b)(6) 2017.The surgeon indicated that nothing was wrong with the ring.Rather, he chose to replace the mitral valve after first attempting to repair the valve with the memo ring.

• Brand Name: MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia 13040 ; IT 13040
• MDR Report Key: 7065644
• Report Number: 3005687633-2017-00118
• Device Sequence Number: 16182000
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)210920
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: Physician
• Device Expiration Date: 09/20/2021
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 11/28/2017
• 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: 75 YR