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

Model Number LXA

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

Device is not yet available for analysis.

Event Description

The manufacturer was informed on 26 oct 2016 through patient tracking form for patient who had a mitroflow lxa25 implanted in 2012.Details as: lxa25 sn # (b)(4) was implanted on (b)(6) 2012 at (b)(6).R5-023 sn # (b)(4) was implanted on (b)(6) 2016 at (b)(6).No further information provided.

Manufacturer Narrative

The complete manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, 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 lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.Further information has been requested from the physician by the manufacturer.Based on limited information received the root cause cannot yet be determined at this time.The device is not available for return or analysis no further investigation is possible at this time.Not available for return.

• 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 V5J 5 M1; CA V5J 5M1
• Manufacturer (Section G): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby,
• Manufacturer Contact: francesca crovato ; 5005 north fraser way; burnaby, bc ; 4125696
• MDR Report Key: 6126457
• MDR Text Key: 60848113
• Report Number: 3004478276-2016-00155
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)161212
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060038/S002
• 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,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/12/2016
• Device Model Number: LXA
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2012
• 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): Required Intervention
• Patient Age: 54 YR