MAUDE Adverse Event Report: SORIN GROUP USA/LIVA NOVA USA, INC TISSUE VALVE AORTIC 23MM; HEART-VALVE MECHANICAL

Catalog Number CNA23

Device Problem Structural Problem (2506)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2019

Event Type  Injury  

Event Description

Cath lab: symptomatic bioprosthetic aortic valve stenosis patient status post aortic valve replacement with sorin 23 mm valve on (b)(6) 2017.Fda safety report id # (b)(4).

• Brand Name: TISSUE VALVE AORTIC 23MM
• Type of Device: HEART-VALVE MECHANICAL
• Manufacturer (Section D): SORIN GROUP USA/LIVA NOVA USA, INC
• MDR Report Key: 8790474
• MDR Text Key: 151308828
• Report Number: MW5088088
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CNA23
• Device Lot Number: JK973
• 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: 62 YR