MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	TFGT-25A
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility medwatch report # mw5119778 received that states ¿i had aortic valve replaced in (b)(6) 2016 with a abbott trifecta gt.I was informed valve would last 10 to 20 years on average.I was hospitalized in (b)(6) 2023 as i could not breathe and was diagnosed with congested heart failure due to sudden aortic valve failure.I had open heart surgery to remove the trifecta gt valve and all associated parts it was replaced by a different manufacturers valve.Upon removal the trifecta valve was found to have severe stenosis and two of the three leaflets were torn per surgeon.I am truly blessed to be alive.Heart catheterization, mri, ekg, heart ultra sound, x ray, blood work." it was reported that on (b)(6) 2016, a 25mm trifecta gt valve was successfully implanted during an aortic valve replacement.In 2023, the patient was hospitalized with shortness of breath.The patient was diagnosed with congestive heart failure due to aortic valve failure.On (b)(6), 2023, the patient underwent surgery to explant the device and replace with a non-abbott valve.Upon removal of the valve, it was found to have severe stenosis and two of the three leaflets were torn.The patient status was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Explant due to congestive heart failure due to aortic valve failure and shortness of breath was reported.Field indicated that it was found to have severe stenosis and two of the three leaflets were torn.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on received information, the cause of reported incident could not be conclusively determined.

• Brand Name: TRIFECTA¿ GT VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17661869
• Report Number: 2135147-2023-03793
• Device Sequence Number: 6247050
• Product Code: LWR
• UDI-Device Identifier: 05415067018236
• UDI-Public: 05415067018236
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 10/17/2020
• Device Catalogue Number: TFGT-25A
• Device Lot Number: 5715174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male