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

Model Number LXA19

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Material Too Rigid or Stiff (1544)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Death (1802)

Event Date 03/29/2017

Event Type  Death  

Manufacturer Narrative

The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa19, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova (b)(4) corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa19 mitroflow aortic pericardial heart valve at the time of manufacture and release.The device is not available for return and no further information is available for the reported event.The manufacturer is unable to perform any further investigations.Structural valve deterioration is a known inherent risk of failure for biological implants.However, because no further investigations are possible the root cause cannot be established at this time.

Event Description

A patient was implanted with a mitroflow lx19 (sn (b)(4)) on (b)(6) 2013.The patient death was reported to be related to the premature failure of the mitroflow valve.Medical records reported from (b)(6) medical center reported that the valve failure was due severe valve calcification and leaflets fixed.On (b)(6) 2017 toe reported that ¿ the aortic valve leaflets are severely thickened with reduced systolic excursion.Severe aortic calcification is visualized.Mean gradient was reported to be 97mmhg.

• Brand Name: MITROFLOW LXA
• 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: 8837280
• MDR Text Key: 152523887
• Report Number: 3004478276-2019-00230
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)171031
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2012
• 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; Hospitalization
• Patient Age: 69 YR