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

Model Number LXA25

Device Problem Calcified (1077)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849)

Event Type  Injury  

Manufacturer Narrative

As the valve was not received for analysis and the serial number remains unknown, no device investigation can be performed.It is possible that the patients clinical condition and risk factors contributed to the reported degeneration; however, as limited patient information is known this cannot be confirmed and the root cause remains unknown.It should be noted that structural valve deterioration is listed in the perceval ifu among the possible adverse events associated with cardiac valve replacement with a bioprosthesis.The reported event is therefore a known, inherent risk of the procedure.

Event Description

A mitroflow lxa25 was implanted on (b)(6) 2012.The operation was reportedly a success.In the months after the operation, the patient reported recurrence of his pre-operative symptoms (shortness of breath, sensation in chest, lethargy).On (b)(6) 2013, an echocardiogram was performed, which did not reveal any abnormalities.In (b)(6) 2014, the patient returned with the same symptoms, and was referred for education on aortic valve stenosis and exercise.In (b)(6) 2014, the patient returned for follow-up, again with persistent symptoms.Another echo was performed, and a follow-up echo was scheduled for one year later.The patient's symptoms persisted until 2015.They reportedly had recurrent attacks -3-4 times per week, almost resulting in loss of consciousness.On (b)(6) 2015, a second physician reviewed the patient's medical records and echo results, and it was declared that the replacement had failed and required replacement.In (b)(6) 2016, reoperation was performed due to calcification of the valve leaflets.

• 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 V5J5M 1; CA V5J5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia V5J5M 1; CA V5J5M1
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc V5J5M-1 ; CA V5J5M1
• MDR Report Key: 8636892
• MDR Text Key: 145957868
• Report Number: 3004478276-2019-00167
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2019
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention