MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW DLA; TISSUE HEART VALVE

Model Number DLA21

Device Problem Leak/Splash (1354)

Patient Problem Aortic Regurgitation (1716)

Event Date 06/18/2020

Event Type  Injury  

Event Description

The manufacturer was notified of the following event through the fda's medwatch program (mw5095353).It was reported on (b)(6) 2015 a patient received a mitroflow dla21 as part of an avr.In 2020 the patient tee showed mild to moderate regurgitation.On (b)(6) 2020 the patient had a reintervention.No further information is available, and the device is not available for analysis.No explant was confirmed.

• Brand Name: MITROFLOW DLA
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 10510701
• MDR Text Key: 206301715
• Report Number: 1718850-2020-01134
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2020,08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLA21
• Device Catalogue Number: DLA21
• 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: 07/02/2020
• Distributor Facility Aware Date: 08/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention