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

Model Number	TFGT-27A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9742098
• Report Number: 3008452825-2020-00055
• Device Sequence Number: 1973981
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: 05415067018243
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 05/05/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/13/2020; 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention