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

Model Number	LXA19
Medical Device Problem Codes	Calcified (1077); Gradient Increase (1270); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Codes	Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Death (1802)
Date of Event	03/29/2017
Type of Reportable Event	Death
Event or Problem Description
A patient was implanted with a mitroflow lx19 (sn (b)(4)) on (b)(6) 2013.The patient death was reported to be related to the premature failure of the mitroflow valve.Medical records reported from (b)(6) medical center reported that the valve failure was due severe valve calcification and leaflets fixed.On (b)(6) 2017 toe reported that ¿ the aortic valve leaflets are severely thickened with reduced systolic excursion.Severe aortic calcification is visualized.Mean gradient was reported to be 97mmhg.".

• 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: 8834868
• Report Number: 1718850-2019-01045
• Device Sequence Number: 2078720
• Product Code: LWR
• UDI-Device Identifier: 00896208000092
• UDI-Public: (01)00896208000092(240)LXA19(17)171031
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2019
• Report Date (Section F): 07/03/2019

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: 10/31/2017
• Device Model Number: LXA19
• Device Catalogue Number: LXA19
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2019
• Device Age: 55 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: Not provided
• 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: Death; Hospitalization
• Patient Age: 69 YR