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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, PUERTO RICO SJM MASTERS SERIES MECHANICAL HEART VALVE
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ST. JUDE MEDICAL, PUERTO RICO SJM MASTERS SERIES MECHANICAL HEART VALVE Back to Search Results
Model Number 31MJ-501
Device Problem Material Integrity Problem (2978)
Patient Problems Infarction, Cerebral (1771); Death (1802)
Event Date 01/22/2014
Event Type  Injury  
Event Description
The info provided to sjm indicated a 31mm masters series valve was selected for use.The subvalvular structures were impeding the valve.It was discovered that one of the leaflets was not opening correctly.The valve was rotated and the position changed but the problem persisted.The patient was on and taken off cardiopulmonary bypass four times.After four attempts, another 31mm masters series valve was implanted (31mj-501:s/n (b)(4).The patient expired two days post-op due to a stroke.
 
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Brand Name
SJM MASTERS SERIES MECHANICAL HEART VALVE
Manufacturer (Section D)
ST. JUDE MEDICAL, PUERTO RICO
caguas PR
Manufacturer Contact
denise johnson, rn
177 east county road b
st. paul, MN 55117
6517564470
MDR Report Key3647944
MDR Text Key4182647
Report Number2648612-2014-00010
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeAL
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/22/2018
Device Model Number31MJ-501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/24/2014
Date Device Manufactured10/23/2013
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 Age55 YR
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