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

Model Number	TFGT-29A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
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 an unknown date, a 29mm trifecta gt valve was selected for implant.After implant, the patient experienced severe aortic insufficiency, and the valve was explanted.An edwards inspiris resilia tissue valve (size unknown) was implanted.The explant resulted in extended cross-clamp time.The patient is reported to be recovering.Additional information has been requested.
Additional Manufacturer Narrative
The reported event of aortic insufficiency could not be confirmed.All three leaflets were mobile and no damage or other anomalies were noted with the valve leaflets.The device was not available for functional testing, limiting the investigation to morphological examination and a review of the device history record.That review concluded that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Hydrodynamic functional testing at the time of manufacturing indicated the valve functioned normally.The cause of the reported event could not be conclusively determined.
Event or Problem Description
On an unknown date, a 29mm trifecta gt valve was selected for implant.After implant, the patient experienced severe aortic insufficiency, and the valve was explanted.An edwards inspiris resilia tissue valve (size unknown) was implanted.The explant resulted in extended cross-clamp time.The patient is reported to be recovering.Additional information has been requested, but unavailable.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: 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: 8593455
• Report Number: 3008452825-2019-00225
• Device Sequence Number: 16654631
• Product Code: LWR
• UDI-Device Identifier: 05415067018250
• UDI-Public: 05415067018250
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100029/S021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 06/19/2022
• Device Model Number: TFGT-29A
• Device Catalogue Number: TFGT-29A
• Device Lot Number: 6532878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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