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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 VALVES
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LIVANOVA CANADA CORP PERCEVAL SUTURELESS AORTIC HEART VALVE; TISSUE HEART VALVES Back to Search Results
Model Number PVS25
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Complete Heart Block (2627)
Event Date 06/27/2019
Event Type  Injury  
Event Description
The manufacturer was informed on this event through the sure avr study.On (b)(6) 2019, a patient received a pvs25 in aortic position.Sizing difficulties occurred during the procedure, specified as an imperfect alignment along the non-coronary sinus.The procedure was performed in mini-thoracotomy.On (b)(6) 2019, the site reports that the patient received a permanent pacemaker due to an atrioventricular block grade iii, defined as a new conduction abnormality for this patient.Pre-operatively, the patient was in regular sinus rhythm.The patient was discharged to a rehabilitation clinic on (b)(6) 2019.
 
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Brand Name
PERCEVAL SUTURELESS AORTIC HEART VALVE
Type of Device
TISSUE HEART VALVES
Manufacturer (Section D)
LIVANOVA CANADA CORP
5005 north fraser way
burnaby, british columbia
MDR Report Key9420455
MDR Text Key176228724
Report Number1718850-2019-01197
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 11/07/2019,01/10/2020
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 Model NumberPVS25
Device Catalogue NumberICV1210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/07/2019
Event Location Hospital
Date Report to Manufacturer11/07/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/05/2019
Supplement Dates Manufacturer Received11/07/2019
Supplement Dates FDA Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age82 YR
Patient Weight82
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