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  

Manufacturer Narrative

The manufacturer presently has no contact information for reporter and the device is not available.At this time no investigations can be performed and the root cause cannot be established.Device not available.

Event Description

The manufacturer was notified of the following event through the fda's medwatch program (mw5095353).It was reported on oct.25, 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
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• Manufacturer Contact: francesca crovato ; 5005 n fraser way; burnaby, bc V5J 5-M1 ; CA V5J 5M1
• MDR Report Key: 10510762
• MDR Text Key: 206310867
• Report Number: 3004478276-2020-00184
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention