MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL 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	Mitral Regurgitation (1964)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020 a patient was intended to receive a memo 3d 30mm mechanical mitral repair ring as part of an mvr to treat a patient with mitral regurgitation due to infective endocarditis.The manufacturer was notified that the regurgitation did not stop and the product was explanted intra-operatively and replaced with another product.There was a tear in the commissure portion of the rcc and ncc causing regurgitation.The patient is still being treated.No further information was received.
Additional Manufacturer Narrative
The device involved in the reported event was returned to the manufacturer and it was received on 02 nov 2020.After decontamination, a visual inspection was performed which did not highlight the presence of pre-existing defects.Some light trace of manipulation were detected, and are consistent with the normal handling maneuvers to release the device from the template / holder.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 investigation performed, no device malfunctions were identified and it was confirmed that the device met the manufacturing standards.As such, the root cause of the reported event cannot be traced to the device.Based on the information reported, stating that the device was explanted as the regurgitation was not resolved and that a tear was identified causing the regurgitation, the root cause can be traced to the procedure.The manufacturer will re-assess the event should further information be provided.

• Brand Name: MEMO 3D SEMIRIGID ANNULOPLASTY RING
• Common Device Name: MITRAL ANNULOPLASTY RING
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada crescentino snc; saluggia, vercelli
• MDR Report Key: 10659772
• Report Number: 1718850-2020-01165
• Device Sequence Number: 14245042
• Product Code: KRH
• UDI-Device Identifier: 08022057013125
• UDI-Public: (01)08022057013125(240)ICV0969(17)250412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020
• Report Date (Section F): 09/11/2020

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: 04/12/2025
• Device Model Number: SMD30
• Device Catalogue Number: ICV0969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/02/2020
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/02/2020
• 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