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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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ST. JUDE MEDICAL, COSTA RICA LTDA SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number TF-25A
Device Problems Leak/Splash (1354); Material Split, Cut or Torn (4008)
Patient Problem Aortic Insufficiency (1715)
Event Date 12/13/2018
Event Type  Injury  
Event Description
In 2016, a 25mm trifecta valve was implanted.On (b)(6) 2018, the 25mm trifecta valve was explanted due to leaflet tear and leakage.A perimount valve was implanted.The patient is reported stable.Echo and op reports were requested, but not made available.
 
Manufacturer Narrative
An event of leakage was reported.The reported tear was confirmed, as leaflet 3 contained a partial thickness tear in its base.There was also a horizontal fold in leaflet 3, creating incomplete coaptation.A thin layer of organizing thrombus was found on the inflow and outflow surface of all three leaflets, with areas of degenerating acute inflammatory cells in leaflets 1 and 2.No significant calcifications were present and a gram stain was negative for bacteria.The reported leakage is consistent with the folded leaflet creating incomplete coaptation.The root cause of the folded leaflet could not be conclusively determined.
 
Event Description
In 2016, a 25mm trifecta valve was implanted.On (b)(6) 2018, the 25mm trifecta valve was explanted due to leaflet tear and leakage.A perimount valve was implanted.The patient is reported stable.Echo and op reports were requested, but not made available.
 
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Brand Name
SJM TRIFECTA 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 Key8192472
MDR Text Key131300873
Report Number3008452825-2018-00431
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 03/04/2019
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 Model NumberTF-25A
Device Catalogue NumberTF-25A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received02/08/2019
Supplement Dates FDA Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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