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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST. JUDE MEDICAL, COSTA RICA LTDA TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number CVD0027
Device Problem Backflow (1064)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
Further information regarding this event has been requested.The results/ method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
It was reported through a user report that possibly 10 trifecta valves were implanted on unknown dates.The valves were explanted due to early structural deterioration.Patient specifics are unknown.Additional information has been requested but cannot be obtained.
 
Manufacturer Narrative
An event of early failure and replacement of 10 trifecta valves was reported.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
TRIFECTA STENTED TISSUE VALVE
Type of Device
HEART-VALVE, NON-ALLOGRAFT TISSUE
Manufacturer (Section D)
ST. JUDE MEDICAL, COSTA RICA LTDA
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 01897 -405
CS  01897-4050
MDR Report Key10013904
MDR Text Key189882032
Report Number3008452825-2020-00218
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
PMA/PMN Number
P100029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCVD0027
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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