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

Model Number TF-A

Device Problems Calcified (1077); Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 04/01/2021

Event Type  Injury  

Event Description

The abstract article, "trifecta bioprostheses: evaluation of the safety based on the study of degenerations according to the varc-3 classification", was reviewed.The research article is a retrospective single center experience to evaluate the intrinsic imputability of trifecta for dysfunction according to the varc-3 classification in patients implanted and to reassess their referencing in our center.Trifecta valve was the device associated with this study.The article concluded, the classification of failures according to varc-3 indicated the intrinsic imputability of the trifecta¿ bioprostheses regarding to the number of svd-type dysfunctions.Although this study has limitations, it shows the understatement of medical-devices-vigilance cases by the medical staff.[the primary author of this article is richez, ophelie, amiens-picardie university hospital, 1 rond-point du professeur christian cabrol, 80054 amiens, france, with email address of : richez.Ophelie@chu-amiens.Fr].It was reported that on an unknown date in (b)(6) 2013, a 23mm trifecta valve was implanted for native valve endocarditis of a 37 year old patient.The trifecta was implanted at the aortic and the perimount at the mitral valve.In april of 2021, it was reported dyspnea progressively increased during the 3 to 4 months and the aortic valve showed a stenosant image and central aortic leak grade 1.In (b)(6) 2021, a bioprothesis degeneracy was reported.In (b)(6) 2021, an aortic prothesis degeneracy was reported and a reoperation was necessary.On (b)(6) 2021, ultrasound showed the left ventricle ejection fraction of 55%, slightly dilated left ventricle, inferiror vena cava vein dilated but compliant.There was also grade 1 tricuspid leak, stenosis noted on aortic prosthesis and leakage with a gradient of 86 mmhg.In august of 2021, the trifecta valve was replaced with a 21 mm sjm regent heart valve w/flex cuff.The removed trifecta valve was totally destroyed and calcified, and the patient suffered with multiple post-surgical complications.In (b)(6) 2021, the patient passed due to a cardiogenic and septic shock due to massive inhalation at the second coma, refractory to any therapy, with serious mixt sdra (acute respiratory distress syndrome).Undo.

Manufacturer Narrative

As reported in a research article a patient had the valve explanted 8 years after implant due to valve degeneracy, with the patient having multiple post-surgical complications.The patient was reported to have passed away about 3 months later due to a cardiogenic and septic shock due to massive inhalation at the second coma, refractory to any therapy, with acute respiratory distress syndrome.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis, however it was indicated that the valve was "totally destroyed" and calcified upon explant, which would the cause the valve to malfunction.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: 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: 16817349
• MDR Text Key: 314039732
• Report Number: 2135147-2023-01836
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052030
• UDI-Public: 05414734052030
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2013
• Device Model Number: TF-A
• Device Catalogue Number: TF-23A
• Device Lot Number: 3538399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR