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

Model Number	LXA
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Calcium Deposits/Calcification (1758)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown if device was explanted.
Event or Problem Description
The manufacturer was notified on 25 aug 2016 that a patient who was implanted with mitroflow lxa, size 21 on (b)(6) 2014 showed restricted leaflet movement due to calcification.No further information provided.
Additional Manufacturer Narrative
Design history record review completed mar 1, 2017.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).The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model lx) mitroflow aortic pericardial heart valve at the time of manufacture and release.
Event or Problem Description
The manufacturer was notified on 25 aug 2016 that a patient who was implanted with mitroflow lxa, size 21 on (b)(6) 2014 showed restricted leaflet movement due to calcification.The manufacturer was notified that the device was explanted on (b)(6) 2017 and replaced by a carbomedics standard aortic mechanical heart valve, a5-021.
Additional Manufacturer Narrative
The manufacturer was notified that the device was explanted on (b)(6) 2017 and replaced by a carbomedics standard aortic mechanical heart valve, a5-021.The manufacturer is following up to obtain further information regarding the explant and device availability.If further information is received the manufacturer will update the competent authority.

• 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: 5968462
• Report Number: 3004478276-2016-00096
• Device Sequence Number: 81150
• Product Code: DYE
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)180831
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: P060038/S002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2018

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: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: LXA
• Device Catalogue Number: LXA21
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2016
• Supplement Date Received by Manufacturer: Not provided; 05/10/2018
• Initial Report FDA Received Date: 09/21/2016
• Supplement Report FDA Received Date: 04/07/2017; 09/21/2018
• 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: Other; Required Intervention
• Patient Age: 60 YR