MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TFGT-23A

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Aortic Insufficiency (1715); Arrhythmia (1721); Pleural Effusion (2010)

Event Date 05/25/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2017, a 23 mm trifecta gt valve was implanted.On (b)(6) 2017, the patient was diagnosed with anemia and required a blood transfusion on (b)(6) 2017.The patient also developed bilateral pleural effusions which were drained and only a small effusion remained on the right side on (b)(6) 2017.The patient was diagnosed with tachyarrhythmia which was treated with a medication adjustment and at discharge the ecg showed sinus rhythm.(clinical study patient id: (b)(6)).

Event Description

On (b)(6) 2017, a 23 mm trifecta gt valve was implanted.On (b)(6) 2017, the patient was diagnosed with anemia and required a blood transfusion on (b)(6) 2017.The patient also developed bilateral pleural effusions which were drained and only a small effusion remained on the right side on (b)(6) 2017.The patient was diagnosed with tachyarrhythmia which was treated with a medication adjustment and at discharge the ecg showed sinus rhythm.Additional information received on (b)(6) 2018 indicated that at the 6 month visit on (b)(6) 2017, aortic insufficiency (mild grade i) was detected without any functional problem.No treatment was required.(clinical study patient id: (b)(6)).

• Brand Name: TRIFECTA¿ GT 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 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 Key: 6686162
• MDR Text Key: 79053653
• Report Number: 3008452825-2017-00144
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

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 Expiration Date: 01/03/2021
• Device Model Number: TFGT-23A
• Device Catalogue Number: TFGT-23A
• Device Lot Number: 5821028
• Other Device ID Number: 05415067018229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 80