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

Model Number DLA19

Device Problem Infusion or Flow Problem (2964)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure (2206)

Event Date 07/31/2017

Event Type  Injury  

Manufacturer Narrative

No indication of device explant.

Event Description

The manufacturer was notified of a serious adverse event involving a livanova product via the department of health and human services.Medwatch fda # mw5088087 on (b)(6) contained the following event.On 2017 acute decompensated heart failure due to early stenosis of sorin aortic valve 23 mm.Fda safety report id # (b)(4).The device in question is a mitroflow dla19 which was implanted on (b)(6) 2015.No further information was received.

Manufacturer Narrative

Based on the information received from the fda it is not possible to perform any investigations as the specific device serial number is unknown and the device is not available.Structural valve deterioration is known inherent risk of device for biological valve implants.At this time based on the information available the root cause cannot be established.

• Brand Name: MITROFLOW DLA
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 8928061
• MDR Text Key: 156286885
• Report Number: 3004478276-2019-00254
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLA19
• Device Catalogue Number: DLA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization