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

Model Number	SMD32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported from patient registration form that the patient had a mitral repair surgery on (b)(6) 2017 and on (b)(6) 2017 underwent a second mitral repair surgery with a smaller size ring.It was stated that the incorrect size repair (too large) was implanted which led to moderate to severe mitral regurgitation.The ring was replaced with a smaller ring which resolved the issue.The ring was discarded.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MEMO 3D RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L; via crescentino sn; saluggia 13040 ; IT 13040
• MDR Report Key: 6528147
• Report Number: 3005687633-2017-00041
• Device Sequence Number: 11169563
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)210621
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071327
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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: 06/21/2021
• 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: 03/28/2017
• Initial Report FDA Received Date: 04/27/2017
• 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: 59 YR