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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number CVD0027
Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Patient Problem Aortic Insufficiency (1715)
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
On an unknown date, a trifecta valve was selected for implant.Two years post-procedure, the patient presented with valvular insufficiency.Additional information has been requested but not yet received.
 
Manufacturer Narrative
An event of valvular insufficiency was reported.A more comprehensive assessment could not be performed as the device remains implanted was 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 (CVD)
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 01897 -405
CS  01897-4050
MDR Report Key10185895
MDR Text Key196160338
Report Number3008452825-2020-00265
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 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
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 Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
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