MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW VALVE MODEL LXA21; TISSUE HEART VALVE

Model Number LXA21

Device Problem Gradient Increase (1270)

Patient Problems Congestive Heart Failure (1783); Death (1802)

Event Date 10/01/2010

Event Type  Death  

Manufacturer Narrative

This event was initially submitted as (fda#3004478276-2016-00150) as a group of events as device information was not available.Additional information, including patient information, date of implant and explant, and serial number have been received as of february 13, 2017.Now that information is available, the initial report is being submitted.

Event Description

The 1st cause of patient death congestive heart failure due to valve svd of 2 pt deaths related to the 23 svd cases mentioned in the paper: (this is also part of the late mortality group) the fate of small size mitroflow valve prostheses in an old patient population - ruggero de paulis.

• Brand Name: MITROFLOW VALVE MODEL LXA21
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 6408374
• MDR Text Key: 70055063
• Report Number: 3004478276-2017-00022
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2010
• Device Model Number: LXA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR