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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, PUERTO RICO, INC. SJM MECHANICAL HEART VALVE
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ST. JUDE MEDICAL, PUERTO RICO, INC. SJM MECHANICAL HEART VALVE Back to Search Results
Model Number 25A-101
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Thrombosis (2100)
Event Date 02/01/2014
Event Type  Injury  
Event Description
The information provided to sjm indicated a 25mm sjm mechanical heart valve was explanted due to valvular thrombosis.The valve had been implanted in 1996.Intraoperatively, the valve was well seated with thrombus on both sides of the valve centered around the hinge points.Mild pannus ingrowth on the ventricular side and calcification on the sewing ring were observed.It was replaced with a 25mm mcri on-x mechanical valve.
 
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Brand Name
SJM MECHANICAL HEART VALVE
Manufacturer (Section D)
ST. JUDE MEDICAL, PUERTO RICO, INC.
caguas PR
Manufacturer Contact
denise johnson, rn
177 east county road b
st. paul, MN 55117
6517564470
MDR Report Key3687844
MDR Text Key21449403
Report Number2648612-2014-00015
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P810002
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 02/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/05/1999
Device Model Number25A-101
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/1995
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 Age44 YR
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