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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE
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LIVANOVA CANADA CORP. PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVE Back to Search Results
Model Number TBD
Device Problem Leak/Splash (1354)
Patient Problem Aortic Regurgitation (1716)
Event Type  Injury  
Event Description
The manufacturer was notified that a patient received a perceval valve in (b)(6) 2019, which was explanted in (b)(6) 2019.Severe aortic regurgitation was identified prior to the re-intervention.
 
Manufacturer Narrative
Fields updated: b4, f6, f7.The manufacturer attempted to retrieve additional information on the event, but no further information has been received to date despite the attempts.As the device was not returned for analysis and the serial number remains unknown, no further investigation is possible at this time.Based on the available information, the manufacturer is unable to establish a definitive conclusion for the reported event.The root cause of the explant and aortic regurgitation remain unknown at this time.Should further information be provided in the future, the manufacturer will re-assess the event and provide an update to this reporting activity.
 
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Brand Name
PERCEVAL SUTURELESS AORTIC HEART VALVE
Type of Device
TISSUE HEART VALVE
Manufacturer (Section D)
LIVANOVA CANADA CORP.
5005 north fraser way
burnaby, bc
MDR Report Key10946769
MDR Text Key219555191
Report Number1718850-2020-01207
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 11/04/2020,01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTBD
Device Catalogue NumberTBD
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/15/2020
Event Location Hospital
Date Report to Manufacturer11/04/2020
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
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