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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA CANADA CORP. MITROFLOW DLA; TISSUE HEART VALVE
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LIVANOVA CANADA CORP. MITROFLOW DLA; TISSUE HEART VALVE Back to Search Results
Model Number DLA21
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 02/07/2019
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2015 a patient received a mitroflow dla21 aortic heart valve implant.The manufacturer was notified that the device was explanted on (b)(6) 2019 and replaced with a perceval pvs21 sutureless aortic heart valve implant.No further information was received.
 
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Brand Name
MITROFLOW DLA
Common Device Name
TISSUE HEART VALVE
Manufacturer (Section D)
LIVANOVA CANADA CORP.
5005 north fraser way
burnaby, bc
MDR Report Key8770017
Report Number1718850-2019-01006
Device Sequence Number2102720
Product Code LWR
UDI-Device Identifier00896208000160
UDI-Public(01)00896208000160(240)DLA21(17)160630
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 09/13/2019
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 Date06/30/2016
Device Model NumberDLA21
Device Catalogue NumberDLA21
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/12/2019
Event Location Hospital
Initial Date Received by Manufacturer Not provided
Supplement Date Received by Manufacturer06/12/2019
06/12/2019
Initial Report FDA Received Date07/08/2019
Supplement Report FDA Received Date08/12/2019
09/14/2019
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 Age75 YR
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