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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 LXA25
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 11/16/2015
Type of Reportable Event Serious Injury
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).
 
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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 Key8839625
Report Number1718850-2019-01046
Device Sequence Number2755071
Product Code LWR
UDI-Device Identifier00896208000122
UDI-Public(01)00896208000122(240)LXA25(17)180228
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/29/2019
Report Date (Section F) 07/02/2019
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 Date02/28/2018
Device Model NumberLXA25
Device Catalogue NumberLXA25
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/02/2019
Device Age33 MO
Event Location Hospital
Date Report to Manufacturer07/02/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
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