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

Model Number	LXA
Medical Device Problem Codes	Material Deformation (2976); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Information (3190)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We acknowledge the late reporting of the case.This information was received through patient tracking form that device was explanted and another device was implanted.No further information about the reason for explant was provided.Livanova is trying to obtain further information.Not returned.
Event or Problem Description
The manufacturer was notified through patient registration form ((b)(4)) on (b)(6) 2016 that a mitroflow valve lxa21 sn# (b)(4) was implanted on (b)(6) 2012 was explanted on (b)(6) 2016 and another device was implanted.No further information was provided.
Additional Manufacturer Narrative
Device not returned to manufacturer.
Additional Manufacturer Narrative
Further information has been requested from the physician by the manufacturer but has not been received to date.Based on limited information known the root cause cannot yet be determined at this time.The device is not available for return or analysis.
Event or Problem Description
On (b)(6) 2017 a mitroflow valve lxa21 sn#(b)(4) that was implanted on (b)(6) 2012 was explanted due to calcification after approx 4 yrs implant duration.A pereval size 23mm was then implanted, no further information known to the manufacturer.

• Brand Name: MITROFLOW AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 5984986
• Report Number: 3004478276-2016-00110
• Device Sequence Number: 11125707
• Product Code: DYE
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)160228
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P060038/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2017

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
• Operator of Device: No Information
• Device Expiration Date: 02/28/2016
• Device Model Number: LXA
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided; 11/30/2017
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 05/30/2017; 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR