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

Model Number	LXA25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	11/16/2015
Type of Reportable Event	Serious Injury
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 (b)(4) 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 device is not available for return and no further information is available for the reported event.The manufacturer is unable to perform any further investigations.Because no further investigations are possible the root cause cannot be established at this time.Device evaluated by mfr: tavi performed.
Event or Problem Description
A patient was implanted with a mitroflow lxa25 sn (b)(4) on (b)(6) 2013 at (b)(6) medical center (b)(6).At 2 years follow-up valve showed failure with severe bio-prosthetic aortic stenosis.On (b)(6) 2015 a tavi was performed at (b)(6) medical center in (b)(6).

• 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: 8839641
• Report Number: 3004478276-2019-00231
• Device Sequence Number: 2457523
• Product Code: LWR
• UDI-Device Identifier: 00896208000122
• UDI-Public: (01)00896208000122(240)LXA25(17)180228
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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: 02/02/2018
• Device Model Number: LXA25
• Device Catalogue Number: LXA25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/29/2019
• 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: Required Intervention
• Patient Age: 65 YR