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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST JUDE MEDICAL BIOCOR STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST JUDE MEDICAL BIOCOR STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number B10-25A-00
Device Problem Perivalvular Leak (1457)
Patient Problem Aortic Valve Stenosis (1717)
Event Date 05/20/2014
Event Type  Injury  
Event Description
The patient underwent aortic valve replacement with this 25mm sjm biocor stented valve.A coronary artery bypass was also performed at this time and decalcification was required prior to implantation.On (b)(6), 2014 the patient presented with symptoms of aortic stenosis.An echocardiogram revealed paravalvular regurgitation with no evidence of stenosis.The valve was explanted and replaced with a smaller 23mm sjm trifecta tissue valve.During the procedure it was noted one of the cusps was not opening fully.The patient was discharged in stable condition.
 
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Brand Name
BIOCOR STENTED PORCINE HEART VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ST JUDE MEDICAL
nova lima
BR 
Manufacturer Contact
denise johnson, rn
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key3906830
MDR Text Key19716801
Report Number3001743903-2014-00031
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/07/2009
Device Model NumberB10-25A-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/23/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/20/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/08/2005
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
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