TRIFECTA? GT VALVE TFGT-25A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for TRIFECTA? GT VALVE TFGT-25A manufactured by St. Jude Medical, Costa Rica Ltda (cvd).

Event Text Entries

[184149196] An event of insufficiency, which was suspected to be due to a torn leaflet, was reported. The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[184149197] On (b)(6) 2016, a 25mm trifecta gt valve was implanted. The annual echocardiogram (echo) performed on (b)(6) 2018 and (b)(6) 2019 showed the valve working as intended. On (b)(6) 2020, the patient presented with aortic insufficiency from an echo exam. It was suspected that the insufficiency was due to leaflet tear. A valve in valve with a 26mm sapien valve is scheduled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008452825-2020-00156
MDR Report Key9855958
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-19
Date of Report2020-03-19
Date Mfgr Received2020-02-25
Device Manufacturer Date2015-12-08
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAMELA YIP
Manufacturer Street5050 NATHAN LANE N
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL, COSTA RICA LTDA (CVD)
Manufacturer StreetPARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL
Manufacturer CityALAJUELA, COSTA RICA 01897-405
Manufacturer CountryCS
Manufacturer Postal Code01897-4050
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIFECTA? GT VALVE
Generic NameHEART-VALVE, NON-ALLOGRAFT TISSUE
Product CodeLWR
Date Received2020-03-19
Model NumberTFGT-25A
Catalog NumberTFGT-25A
Lot Number5337018
Device Expiration Date2017-12-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, COSTA RICA LTDA (CVD)
Manufacturer AddressPARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 01897-405 CS 01897-4050


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2020-03-19

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