MAUDE Adverse Event Report: LIVANOVA SORIN MEMO 28MM 3D RING; MITRAL VALVE RING

Catalog Number MRCS28

Device Problem Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/04/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, (b)(6) y/o male was admitted to (b)(6) with endocarditis.On (b)(6) 2019, he underwent mitral valve repair with a sorin 28mm 3d ring.He was discharged on (b)(6) 2019.On (b)(6), our dept was notified by a physician at (b)(6) hosp that he had undergone an aortic valve surgery, where / when the mitral valve was inspected, the original holder of the ring was retained.The pt underwent mitral valve replacement at that time during the same procedure.

• Brand Name: SORIN MEMO 28MM 3D RING
• Type of Device: MITRAL VALVE RING
• Manufacturer (Section D): LIVANOVA; UK
• MDR Report Key: 9086933
• MDR Text Key: 159753997
• Report Number: 9086933
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2020
• Device Catalogue Number: MRCS28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2019
• Distributor Facility Aware Date: 08/27/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 77