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

Model Number LXA

Device Problem Material Deformation (2976)

Patient Problems Dyspnea (1816); Fatigue (1849); Pain (1994); Vascular System (Circulation), Impaired (2572)

Event Date 09/22/2016

Event Type  Injury  

Event Description

It was reported that the patient reports that she had aortic valve surgery in 2013 and did not have relief after surgery.She reports she had pain all over her body from poor circulation, had trouble breathing and could not walk and was tired all the time.It was stated that the surgeon performed testing and stated the heart valve was not functioning properly and a replacement would be needed.In (b)(6) 2016 the patient underwent a second heart valve surgery.It was reported that the surgeon stated the valve looked corroded after explant and the surgery took a few extra hours to explant the valve.

Manufacturer Narrative

The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(4), were pulled and reviewed by quality control at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa21 mitroflow aortic pericardial heart valve at the time of manufacture and release.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Type of Device: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 fraser north way; burnaby, bc
• Manufacturer Contact: francesca crovato ; 5005 fraser north way; burnaby, bc
• MDR Report Key: 6485377
• MDR Text Key: 72532107
• Report Number: 3004478276-2017-00054
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: LXA
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: 08/25/2017
• Supplement Dates FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• 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): Required Intervention
• Patient Age: 73 YR