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

Model Number	LXA21
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Death (1802); Dyspnea (1816)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering 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.Not explanted - valve-in-valve.
Event or Problem Description
A mitroflow lxa21 was implanted on (b)(6) 2013 due to severe aortic stenosis.In 2019 a valve-in-valve was scheduled due to worsening dyspnea on exertion and fatigue during activities.The patient was in nyha class iii at follow-up in 2019, with a peak gradient of 68 mmhg and an aortic valve area of 0.68 cm2.The patient had diffuse coronary disease and a history of hyperlipidemia and hypertension.Reintervention was performed on (b)(6) 2019.The patient passed away post-operatively on (b)(6) 2019.
Additional Manufacturer Narrative
Correction: the following narrative comments were mistakenly omitted from the previous report: the manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa21, s/n # (b)(4), as they pertain to the reported event, were retrieved and reviewed by quality engineering 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.As the device was not available for return, no device investigation can be performed and the root cause of the event cannot be established.However, no manufacturing deficiencies were identified from the document review performed.It is possible that the patient's specific clinical condition and risk factors (hyperlipidemia, hypertension) contributed to the reported event; however, this is not possible to confirm.The relationship between the patient's death and the device was not reported, and cannot be confirmed.

• Brand Name: MITROFLOW LXA 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: 8356320
• Report Number: 3004478276-2019-00131
• Device Sequence Number: 2082190
• Product Code: LWR
• UDI-Device Identifier: 00896208000108
• UDI-Public: (01)00896208000108(240)LXA21(17)171130
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 11/30/2017
• Device Model Number: LXA21
• Device Catalogue Number: LXA21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 02/20/2019
• 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: Death; Required Intervention
• Patient Age: 69 YR