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

Model Number	LXA19
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	09/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not explanted.
Event or Problem Description
On (b)(6) 2014 a mitroflow lxa19 was implanted as part of the sure-avr trial.On (b)(6) 2014 the patient had a serious adverse event as recorded by the sure-avr clinical registry.The patient had acute renal failure.This was deemed to be not valve related by the site.On (b)(6) 2014 the patient had a 2nd serious adverse event as recorded by the sure-avr clinical registry.The patient had acute respiratory failure.This was deemed to be not valve related by the site.On (b)(6) 2014 the patient had a 3rd serious adverse event as recorded by the sure-avr clinical registry.The patient had cardiac arrhythmia, atrial fibrillation.This was deemed to be not valve related by the site.The site recorded follow-up data from the referring physician on (b)(6) 2016 which indicated the patient had a right bundle branch block.The patients nyha class was elevated from i to ii.On (b)(6) the patient had a 4th serious adverse event as recorded by the sure-avr clinical registry.The patient was diagnosed with breast cancer and received radiotherapy and chemotherapy.This was deemed to be not valve related by the site.On (b)(6) 2016 the patient had a serious adverse event as recorded by the sure-avr clinical registry.The patient had structural valve deterioration due to stiffening from calcification of the mitroflow valve.This was deemed to be symptomatic by the site.The site recorded follow-up data from the referring physician on (b)(6) 2017 which indicated the patients mean gradient had elevated from 16 to 22 mmhg and a 3+ central leak was noted.In addition the patient had been hospitalized for 25 days due to non-cardiac reasons and there nyha class had been elevated to iii.The site recorded follow-up data from a yearly phone checkup on (b)(6) 2018 which indicated the patients mean gradient had increased from 22 to 26 mmhg.
Additional Manufacturer Narrative
The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # lxa19, 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 lxa19 mitroflow aortic pericardial heart valve at the time of manufacture and release.Because the device was not explanted and thus cannot be analysed no further investigations are possible at this time.The manufacturer is unable to determine the root cause of the reported gradient increase/structural valve deterioration at this time.If further event information is received or any new procedures occur the manufacturer will reassess the investigation and notify the competent authorities.Root cause is unknown.

• Brand Name: MITROFLOW LXA
• Common Device Name: TISSUE HEART VALVE
• Manufacturer (Section D): LIVANOVA CANADA CORP.; 5005 north fraser way; burnaby, bc V5J 5 M1; CA V5J 5M1
• MDR Report Key: 7849367
• Report Number: 3004478276-2018-00288
• Device Sequence Number: 1249271
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)180531
• Combination Product (Y/N): N
• Initial Reporter Country: BU
• 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): 10/26/2018

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: 05/31/2018
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/28/2018
• 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: Disability
• Patient Age: 79 YR
• Patient Weight: 83