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

Model Number	TFGT-29A
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
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 29mm trifecta¿ gt valve was implanted.An valve in valve is anticipated to happen in january due to a possible prolapsed cusp.The patient was reported to in unstable condition.Additional information has been request.
Additional Manufacturer Narrative
An event of a possible prolapsed cusp was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.
Event or Problem Description
On (b)(6) 2017, a 29mm trifecta¿ gt valve was implanted.An valve in valve is anticipated to happen in (b)(6) 2021 due to a possible prolapsed cusp.The patient was reported to in unstable condition.Additional information has been request but cannot be obtained.

• Brand Name: TRIFECTA GT VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); 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: 11135750
• Report Number: 3008452825-2021-00009
• Device Sequence Number: 16731820
• Product Code: LWR
• UDI-Device Identifier: 05415067018250
• UDI-Public: 05415067018250
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: TFGT-29A
• Device Catalogue Number: TFGT-29A
• Device Lot Number: 5860604
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/16/2021
• 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
• Patient Age: 54 YR