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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); Torn Material (3024)
Patient Problems Aortic Insufficiency (1715); Congestive Heart Failure (1783)
Event Date 12/11/2017
Event Type  Injury  
Event Description
On (b)(6) 2015, an aortic valve replacement (avr) was performed and this 25 mm trifecta valve was implanted.Reportedly, the patient's native aortic valve was a congenital bicuspid valve which had raphe on a right coronary cusp (rcc) and a left coronary cusp (lcc).Concomitantly, ascending aortic replacement was performed and a 28 mm j graft (japan lifeline, type straight) was implanted.On (b)(6) 2017, the patient's cardiac function was confirmed to be normal through an echocardiogram with ef of 62% and peak velocity in aortic position of 2.6 m/s.No perivalvular leakage (pvl) was observed.At that time, grade ii of moderate tricuspid regurgitation (tr) was only noted with pressure gradient of 32 mmhg.On (b)(6) 2017, the patient visited to the local clinic.He was treated with administration of antibiotic (zithromax) and supportive measures due to the common cold.On (b)(6) 2017, the patient experienced chest tightness.On (b)(6) 2017, the patient's chest tightness became worse and he presented to emergency room.The patient was hospitalized with congestive heart failure (chf).An ultrasonic cardiogram (ucg) was performed and severe aortic regurgitation (ar) was revealed.Furthermore, a transesophageal echocardiography (tee) revealed that a leaflet became prolapsed to the left ventricular side.Due to acute ar caused by prosthetic valve failure and prolapsed leaflet, the surgical intervention was scheduled.On (b)(6) 2017, re-do avr was performed and this valve was explanted.Upon explant of this valve, a tear was exhibited at the commissure between lcc and rcc toward the nadir of lcc.There was no pannus formation, calcification or evidence of infective endocarditis (ie) observed on the valve.Subsequently, a 23 mm mosaic tissue valve (medtronic) was implanted.The patient remains in unstable condition.Patient identifier and weight are not available due to privacy laws.
 
Manufacturer Narrative
Product: events of ¿severe aortic regurgitation, leaflet becoming prolapsed and a tear¿ were reported.The results of this investigation concluded a tear in the base of leaflet 1.There was fibrous pannus ingrowth on the inflow surface, which narrowed the inflow diameter of leaflets 1 and 3.No acute inflammation or significant calcifications were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported events remain unknown.
 
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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
Manufacturer (Section G)
ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS   1897-4050
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key7178480
MDR Text Key96847810
Report Number3008452825-2018-00010
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/04/2015
Device Model NumberTF-25A
Device Catalogue NumberTF-25A
Device Lot Number4266615
Other Device ID Number05414734052047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2013
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 Age83 YR
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