MAUDE Adverse Event Report: LIVANOVA SORIN MEMO 26MM 3D RING; MITRAL VALVE RING

Catalog Number MRCS26

Device Problem Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2018

Event Type  Injury  

Event Description

On (b)(6) 2016, (b)(6) y/o female underwent elective mitral valve repair with sorin memo 3d ring.She was discharged home on (b)(6) 2016.On (b)(6) 2018, she underwent mitral valve replacement for severe stenosis where the original holder of the ring was retained.

• Brand Name: SORIN MEMO 26MM 3D RING
• Type of Device: MITRAL VALVE RING
• Manufacturer (Section D): LIVANOVA; UK
• MDR Report Key: 9086922
• MDR Text Key: 159753745
• Report Number: 9086922
• 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: 11/09/2020
• Device Catalogue Number: MRCS26
• 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: 06/11/2019
• 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: 48 YR
• Patient Weight: 141