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

Model Number	LXA25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Endocarditis (1834)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device disposition unknown.
Event or Problem Description
The manufacturer was informed that a patient who received a mitroflow lxa25 in 2014, experienced endocarditis (date or timeline of the event is unknown).Based on the information received, the device was reportedly explanted.
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 an lxa25 mitroflow aortic pericardial heart valve at the time of manufacture and release.The manufacturer attempted to follow up to retrieve additional information on the event, but no further information has been received to date.Based on the information available, it is not possible to establish a definitive root cause for the reported event.However, based on the document review performed, no manufacturing no sterilizations deficits were identified.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 LXA 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: 9746245
• Report Number: 3004478276-2020-00126
• Device Sequence Number: 679306
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)190131
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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: 01/31/2019
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: Required Intervention
• Patient Age: 62 YR