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

Model Number	SMD28
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019 a patient received a memo 3d semirigid annuloplasty ring, smd28, icv0968, as part of a mitral valve repair.The manufacturer was notified that the same day the device was explanted and replaced with a second memo 3d, however the size was increased to a smd32, icv0970.No further information was received.
Event or Problem Description
On (b)(6) 2019 a patient received a memo 3d semirigid annuloplasty ring, smd28, icv0968, as part of a mitral valve repair.The manufacturer was notified that the same day the device was explanted and replaced with a second memo 3d, however the size was increased to a smd32, icv0970.No further information was received.The manufacturer received additional information received on sep 27 2019 identifying the original repair didn't work as intended so the surgeon chose a larger size memo to create the correct repair.No allegations were made against the original device.It was regarded as simply a corrected mv repair.
Additional Manufacturer Narrative
The manufacturer received additional information received on sep 27 2019 identifying the original repair didn't work as intended so the surgeon chose a larger size memo to create the correct repair.No allegations were made against the original device.It was regarded as simply a corrected mv repair.Based on the above information there is no indication that the event was related to any device related malfunction.The manufacturer will perform no further investigations and the root cause is deemed to be related to procedural changes.

• 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
• MDR Report Key: 9112927
• Report Number: 1718850-2019-01092
• Device Sequence Number: 3219441
• Product Code: KRH
• UDI-Device Identifier: 08022057013118
• UDI-Public: (01)08022057013118(240)ICV0968(17)210816
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2019
• Report Date (Section F): 08/26/2019

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: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: SMD28
• Device Catalogue Number: ICV0968
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/26/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/27/2019
• 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: 63 YR