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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE TRIFECTA AORTIC VALVE 19MM
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ST. JUDE MEDICAL ST. JUDE TRIFECTA AORTIC VALVE 19MM Back to Search Results
Device Problems Calcified (1077); Occlusion Within Device (1423)
Patient Problem Death (1802)
Event Date 10/25/2017
Event Type  Injury  
Event Description
According to staff, pt had an aortic valve implanted on (b)(6) 2015.Pt returned to the hospital on (b)(6) 2017 with chest pain which resulted in a cabg procedure and replacement of the previous implanted aortic valve due to an occlusion form calcification.Physician was concerned about the amount of calcification of the aortic valve and having to replace the valve after two years.After the surgery procedure, pt deteriorated and expired on (b)(6) 2017 while in the hospital on this admission.This has already submitted to st.Jude and info can be found under (b)(4).
 
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Brand Name
ST. JUDE TRIFECTA AORTIC VALVE 19MM
Type of Device
AORTIC VALVE
Manufacturer (Section D)
ST. JUDE MEDICAL
one st. jude medical drive
st. paul MN
MDR Report Key7058980
MDR Text Key93050895
Report Number7058980
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/17/2017
Distributor Facility Aware Date11/09/2017
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer11/17/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age48 YR
Patient Weight96
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