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

Model Number	LXA25
Medical Device Problem Codes	Degraded (1153); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, 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 lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.Device disposition presently unknown.
Event or Problem Description
The manufacturer was made aware of a serious adverse event which involved a patient with a mitroflow lxa25, via a submission from the tga.The reported information was as follows.Date of implant: (b)(6) 2014.Clinical event information: the death of [redacted] was reported to the coroner.The manner and cause of [redacted] death was found to be 'prosthetic heart valve failure'.A death due to the failure of a medical device is reportable to the tga.The deceased was reportedly a (b)(6) year old woman with a prior medical history of aortic valve replacement in [redacted], hypothyroidism, depression, hypertension, and hyperlipidaemia.The deceased had reportedly been unsteady on her feet for a couple of days, and in the afternoon of [redacted] was seen to be struggling by her husband.The deceased then collapsed and slumped in her chair.An ambulance was called, and the patient was taken to [redacted] hospital for emergency treatment.On arrival at hospital the patient was in cardiorespiratory arrest and extensive resuscitation was attempted.A likely diagnosis of cardiogenic shock secondary to an acute coronary syndrome was made given the presence of chest pain and t wave inversion in leads v2 to v5 and avl of the ecg.Further, there was a poorly contracting left ventricle on bedside echo.The patient's condition was such that she had an extremely low chance of survival even if there was a return of spontaneous circulation, and consequently resuscitation was stopped.At autopsy, there were no injuries.The cause of death was found to be a tear of one of the leaflets of the artificial heart valve which had resulted in significant aortic regurgitation and from there rapid onset heart failure.This is a relatively uncommon cause of sudden death following valve replacement but has been described and can be difficult to diagnose during life.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa25, s/n # (b)(6), 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 lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer reached out to the site for additional information regarding the event.The manufacturer was notified that there is no further information regarding the event available and the device is not available for return.Because the device is not available for return the manufacturers investigation is limited to the device history record review which highlighted no non-conformities at the time of manufacture and release.It is possible that the patient's risk factors (hypertension, and hyperlipidemia) contributed to the reported structural valve deterioration and consequent leaflet tear, as reported in the scientific literature lipid-mediated inflammatory mechanisms may contribute to the svd shetty r1, pibarot p, audet a, janvier r, dagenais f, perron j, couture c, voisine p, després jp, mathieu p.(lipid-mediated inflammation and degeneration of bioprosthetic heart valves.Eur j clin invest.2009 jun;39(6):471-80.Doi: 10.1111/j.1365-2362.2009.02132.).However, since no investigation could be performed, this cannot be ultimately confirmed.Structural deterioration is identified in the ifu as a potential adverse event.

• Brand Name: MITROFLOW LXA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc
• MDR Report Key: 9827522
• Report Number: 3004478276-2020-00134
• Device Sequence Number: 2421456
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)181231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2020

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: 12/31/2018
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/16/2020
• 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
• Patient Age: 72 YR