MAUDE Adverse Event Report: LIVANOVA CANADA CORP MITROFLOW VALVE MODEL LXA21; TISSUE HEART VALVE

Model Number	LXA21
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Mitroflow lxa21 was explanted after 4.68 years and replaced by perceval pvs21.
Additional Manufacturer Narrative
The partial manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(4), were retrieved and reviewed by quality control at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a lxa21 mitroflow aortic pericardial heart valve at the time of manufacture and release.This event was reported to the manufacturer through patient tracking, the manufacturer is in the process of determining further information on this event from the physician.
Additional Manufacturer Narrative
The manufacturer was unable to obtain any further information about this event.It is therefore not possible to determine the root cause of this event, and it remains unknown whether the event was device-related.However, based on the document review performed previously, no manufacturing deficits were identified.Device not available, unable to followup.

• Brand Name: MITROFLOW VALVE MODEL LXA21
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, bc
• MDR Report Key: 6537148
• Report Number: 3004478276-2017-00071
• Device Sequence Number: 905116
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)161130
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P0600038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2018

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: 11/30/2016
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2017
• Supplement Date Received by Manufacturer: 08/18/2017; 01/17/2018
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 09/14/2017; 01/19/2018
• 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: Required Intervention
• Patient Age: 81 YR