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

Model Number	DLA23
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Death (1802); Endocarditis (1834)
Date of Event	02/20/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Not explanted (no autopsy).
Event or Problem Description
The manufacturer was informed on this event through the (b)(4) registry.On (b)(6) 2016, a patient received a mitroflow dla23 in aortic position.A discharge from the hospital, a good device functionality was recorded.The manufacturer was informed that the patient passed away on (b)(6) 2019 due to cardiovascular mortality / all valve-related deaths / endocarditis.Data on the device functionality is available on the database with the following details: (b)(6) 2018 mean gradient 17.4 mmhg, no leaks; (b)(6) 2017 10.6 mmhg, no leaks.Follow up information from the site confirmed that no additional information is available.
Additional Manufacturer Narrative
Fields updated: b4, g4, g7, h1, h2, h6.The manufacturing and material records for the mitroflow bioprosthetic pericardial heart valve, model # dla23, 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 dla23 mitroflow aortic pericardial heart valve at the time of manufacture and release.Since the device was not received for analysis (no autopsy performed), no further investigation is possible at this time.If an infectious microorganism was present on the tissue valve before sterilization, it would be killed very easily by the manufacturer's liquid chemical sterilant.The sterilant contains a mixture of glutaraldehyde, formaldehyde, and alcohol, all of which are highly effective against infectious microorganisms.The manufacturer has validated this liquid chemical sterilization process with spore-forming bacillus atrophaeus, which is the most resistant microorganism known for aldehydes.In addition, the sterile packaging solution used for shipment of mitroflow valves is a 4% formaldehyde solution; the valves remain in this extremely antimicrobial solution until they are opened during surgery.Therefore, it is not conceivable that an infectious microorganism could survive on a valve exposed to the manufacturer's sterilant or the packaging solution.Based on the verification of device sterilization, and given the late onset of the endocarditis, there is no sufficient evidence reasonably suggesting the valve in question was related to the reported endocarditis and the likely cause of the event can reasonably be attributed to patient factors.However, since no further details on the event were received, the root cause of the reported event cannot be definitively stated.Should additional information be received, the manufacturer will reassess the investigation and a follow-up report will be submitted.It should be noted that endocarditis is listed as a potential adverse event in the mitroflow ifu.The event is, therefore, a known inherent risk of the device.

• Brand Name: MITROFLOW DLA AORTIC PERICARDIAL HEART VALVE
• Common Device Name: TISSUE HEART VALVES
• Manufacturer (Section D): LIVANOVA CANADA CORP; 5005 north fraser way; burnaby, british columbia
• MDR Report Key: 9758069
• Report Number: 3004478276-2020-00127
• Device Sequence Number: 688351
• Product Code: LWR
• UDI-Device Identifier: 00896208000177
• UDI-Public: (01)00896208000177(240)DLA23(17)180331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: DLA23
• Device Catalogue Number: DLA23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/05/2020
• 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: 74 YR
• Patient Weight: 97