MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) 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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(6) 2017, a 27mm trifecta¿ gt valve was implanted.On (b)(6) 2020, the valve explanted due to a leaflet tear that was noted on an echocardiogram.The valve was replaced with a on-x prosthetic heart valve.The patient was reported to be in stable condition.Additional information has been requested.
Additional Manufacturer Narrative
The reported event of a torn leaflet could not be confirmed.A more comprehensive assessment could not be performed as 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.Based on the information received, the cause of the reported incident could not be conclusively determined.
Additional Manufacturer Narrative
The reported event of a torn leaflet could not be confirmed.A more comprehensive assessment could not be performed as 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.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, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10403400
• Report Number: 3008452825-2020-00400
• Device Sequence Number: 3672169
• Product Code: LWR
• UDI-Device Identifier: 05415067018243
• UDI-Public: 05415067018243
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: TFGT-27A
• Device Catalogue Number: TFGT-27A
• Device Lot Number: 5796162
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/27/2020; 08/27/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 08/28/2020; 08/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR