MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. AVR SORIN 21MM VALVE; HEART-VALVE, MECHANICAL

Catalog Number DLA21

Device Problem Incomplete Coaptation (2507)

Patient Problem Regurgitation (2259)

Event Date 06/18/2020

Event Type  Injury  

Event Description

Following the placement of the aortic valve on (b)(6) 2015, the patient's tee study (b)(6) 2020 noted: mild to moderate av regurgitation.Fda safety report id# (b)(4).

• Brand Name: AVR SORIN 21MM VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.
• MDR Report Key: 10232714
• MDR Text Key: 197784792
• Report Number: MW5095353
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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: 53 YR
• Patient Weight: 87