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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL TRIFECTA STENTED TISSUE VALVE
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ST. JUDE MEDICAL TRIFECTA STENTED TISSUE VALVE Back to Search Results
Model Number TF-25A
Device Problems Leak/Splash (1354); Material Integrity Problem (2978)
Event Date 12/11/2013
Event Type  Injury  
Event Description
The information provided to sjm indicated a 25mm trifecta valve was implanted on (b)(6) 2010.The pt became symptomatic during the summer of 2013.An echocardiogram revealed leakage through on cusp.The valve was explanted no (b)(6) 2013 and replaced with a 23mm perimount valve.The valve was reportedly torn between the suture ring and cusp.A piece of the cusp was cut and analyzed with no evidence of vegetation.The pt was stable with no adverse effect following the event.
 
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Brand Name
TRIFECTA STENTED TISSUE VALVE
Manufacturer (Section D)
ST. JUDE MEDICAL
saint paul MN
Manufacturer Contact
denise johnson, rn
177 county road b
saint paul, MN 55117-0000
6517564470
MDR Report Key3642016
MDR Text Key4352251
Report Number3007113487-2014-00003
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
P100029
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 01/21/2014
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 Expiration Date10/25/2012
Device Model NumberTF-25A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2014
Initial Date FDA Received02/07/2014
Date Device Manufactured10/17/2010
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 Age71 YR
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