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

Catalog Number DLA19

Device Problem Structural Problem (2506)

Patient Problems Failure of Implant (1924); Heart Failure (2206)

Event Date 07/31/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 acute decompensated heart failure due to early stenosis of sorin aortic valve 23mm.Fda safety report id # (b)(4).

• Brand Name: SORIN AORTIC VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP USA/LIVA NOVA USA, INC.
• MDR Report Key: 8790457
• MDR Text Key: 151308430
• Report Number: MW5088087
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: DLA19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2019
• 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: 86 YR