MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TFGT-27A

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Chest Pain (1776); Dyspnea (1816)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2019, a 27mm trifecta gt valve was implanted.On (b)(6) 2020, the patient presented with complaints indicative of a leaflet tear, including thoracic complaints and exertional dyspnea.On (b)(6) 2020, the valve was explanted and replaced with a competitor's edw resilia valve, which was successfully implanted.The patient is stable.

Manufacturer Narrative

An event of a polyester sewing thread protruding from the nitinol discs was reported.The results of the investigation are inconclusive since the device was not returned for analysis; however, one photo was received for analysis.Based solely on the aforementioned photo, there did appear to be a tear present in one of the leaflets.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

An event of a thoracic complaints, exertional dyspnea and a leaflet tear was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis; however, one photo was received for analysis.Based solely on the aforementioned photo, there did appear to be a tear present in one of the leaflets.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9742098
• MDR Text Key: 183005858
• Report Number: 3008452825-2020-00055
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: 05415067018243
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Model Number: TFGT-27A
• Device Catalogue Number: TFGT-27A
• Device Lot Number: 5977462
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention