MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. SORIN AORTIC VALVE; HEART-VALVE, MECHANICAL

Catalog Number DLA21

Device Problem Degraded (1153)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)

Event Date 02/22/2020

Event Type  Injury  

Event Description

Early prosthetic sorin aortic valve failure with prosthetic aortic stenosis and insufficiency.Valve implanted (b)(6) 2015.On (b)(6) 2020, redo sternotomy with aortic valve replacement utilizing edwards inspiris resilia 23 mm bovine pericardial tissue valve.Fda safety report id# (b)(4).

• Brand Name: SORIN AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.
• MDR Report Key: 9865194
• MDR Text Key: 184665664
• Report Number: MW5093870
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DLA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 106