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U.S. Department of Health and Human Services

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

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LIVANOVA CANADA CORP. MITROFLOW LXA; TISSUE HEART VALVE Back to Search Results
Model Number LXA19
Device Problems Calcified (1077); Gradient Increase (1270); Material Too Rigid or Stiff (1544)
Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Death (1802)
Event Date 03/29/2017
Event Type  Death  
Event 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.".
 
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Brand Name
MITROFLOW LXA
Type of Device
TISSUE HEART VALVE
Manufacturer (Section D)
LIVANOVA CANADA CORP.
5005 north fraser way
burnaby, bc V5J 5 M1
CA  V5J 5M1
MDR Report Key8834868
MDR Text Key152450949
Report Number1718850-2019-01045
Device Sequence Number1
Product Code LWR
UDI-Device Identifier00896208000092
UDI-Public(01)00896208000092(240)LXA19(17)171031
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model NumberLXA19
Device Catalogue NumberLXA19
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/03/2019
Device Age55 MO
Event Location Hospital
Date Report to Manufacturer07/03/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization;
Patient Age69 YR
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