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

Model Number	SMD32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer is following up to determine additional information about this event.Device disposition not presently known.
Event or Problem Description
A memo 3d, size 32, was implanted and explanted on (b)(6) 2018.No other information was provided.
Additional Manufacturer Narrative
Based on the information provided, the event is attributable to mis-sizing/user error.It was reported that there was no problem with the device.No investigation is necessary.Not required for investigation.
Event or Problem Description
A memo 3d, size (b)(6) was implanted and explanted on (b)(6) 2018.The surgeon implanted the device, realized it was too small, and replaced it with a size (b)(6).It was reported that there was nothing wrong with the device, or any harm to the patient.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.; strada crescentino snc; saluggia, vc 13040 ; IT 13040
• MDR Report Key: 7740052
• Report Number: 3005687633-2018-00179
• Device Sequence Number: 11025572
• Product Code: KRH
• UDI-Device Identifier: 08022057013132
• UDI-Public: (01)08022057013132(240)ICV0970(17)220821
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 08/02/2018

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: 08/21/2022
• Device Model Number: SMD32
• Device Catalogue Number: ICV0970
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: 70 YR