MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problems Insufficient Information (3190); Material Split, Cut or Torn (4008)

Patient Problem Heart Failure (2206)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2015, a 21mm trifecta valve was implanted.On an unknown date a valve in valve was performed due to structural valve deterioration.The patient is reported to be in heart failure but in stable condition.Additional information has been requested but not yet received.

Event Description

Additional information received: on (b)(6) 2015, a 21mm trifecta valve was implanted.On an unknown date a valve in valve was performed due to structural valve deterioration.During explant procedure a leaflet tear was observed.The patient is reported to be in heart failure but in stable condition.

Manufacturer Narrative

An event of heart failure and a leaflet tear was reported.The results of the investigation are inconclusive since a valve-in-valve procedure was performed and the device was not accessible 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.

Event Description

Correction: on (b)(6) 2015, a 21mm trifecta valve was implanted.On an unknown date a valve in valve was performed due to structural valve deterioration.During valve in valve procedure a leaflet tear was observed.The patient is reported to be in heart failure but in stable condition.

• 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 Key: 9179316
• MDR Text Key: 161958109
• Report Number: 3008452825-2019-00493
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2016
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4841919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention