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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 Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
On an unknown date, a valve in valve procedure was performed within a 19mm trifecta valve.No information on the reason for the valve-in-valve, patient condition or implant duration was provided.Abbott has requested additional information.
 
Event Description
On an unknown date, a valve in valve procedure was performed within a 19mm trifecta valve.No information on the reason for the valve-in-valve, patient condition or implant duration was provided.No additional information is available.
 
Manufacturer Narrative
An event of a valve-in-valve within a trifecta valve was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.No details on the reason for the valve-in-valve was provided.
 
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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 1897- 4050
CS  1897-4050
MDR Report Key8537788
MDR Text Key142687804
Report Number3008452825-2019-00201
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,health
Type of Report Initial,Followup
Report Date 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCVD0027
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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