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

Model Number	SMD30
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	04/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018 a patient received a memo 3d smd30 mitral repair ring.The manufacturer was notified that the ring was explanted and replaced with a carbomedics standard m7-027 mechanical mitral valve on (b)(6) 2019.The event occurred at (b)(6) and involved dr.(b)(6).No further information was received.
Additional Manufacturer Narrative
A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.
Additional Manufacturer Narrative
On (b)(6) 2018 a patient received a memo 3d smd30 mitral repair ring.The manufacturer was notified that the ring was explanted and replaced with a carbomedics standard m7-027 mechanical mitral valve on (b)(6) 2019.The event occurred at (b)(6) hospital (b)(6) and involved dr.(b)(6).The manufacturer received additional information from the site on sep.10, 2019 identifying the valve had become inefficient in the year between the ring implant and the aortic valve replacement.Upon inspection by cardiology the patient had developed mitral regurgitation.The decision was made to convert to a full valve replacement.The patient was released from the hospital normally and it was identified there were no malfunctions with the meme 3d ring.A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the information received from the site there were no device related issues and the re-operation was a result of patient factors, specifically the degeneration of their native mitral valve requiring replacement.Based on this information no further investigations are required.The manufacturer has concluded the event: cause cannot be traced to device : adverse event related to patient condition.
Event or Problem Description
On (b)(6) 2018 a patient received a memo 3d smd30 mitral repair ring.The manufacturer was notified that the ring was explanted and replaced with a carbomedics standard m7-027 mechanical mitral valve on (b)(6) 2019.The event occurred at (b)(6) hospital (b)(6) and involved dr.(b)(6).The manufacturer received additional information from the site on sep.10, 2019 identifying the valve had become inefficient in the year between the ring implant and the aortic valve replacement.Upon inspection by cardiology the patient had developed mitral regurgitation.The decision was made to convert to a full valve replacement.The patient was released from the hospital normally and it was identified there were no malfunctions with the meme 3d ring.

• 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: 8782259
• Report Number: 1718850-2019-01012
• Device Sequence Number: 11262461
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)220228
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2019

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: 02/28/2022
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2019
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/18/2019; 06/18/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/13/2019; 09/24/2019
• 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: 57 YR