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

Model Number	TF-A
Medical Device Problem Codes	Perivalvular Leak (1457); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Endocarditis (1834); Pericardial Effusion (3271); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article a leaking valve with a vegetation and a tear was found after almost 4 years of implant, which caused the valve to be explanted.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.The leaflet tear noted could have contributed to the reported regurgitation, but the cause of the leaflet tear and endocarditis could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem 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 in (b)(6) 2015, a 21mm trifecta valve was implanted due to severe calcified aortic stenosis and sudden onset dyspnea.Post-op ultrasound showed the trifecta in aortic position with an average gradient of 14mmhg and a small aortic leak that was likely paraprosthetic.The left ventricle was slightly dilated and concentrically hypertrophied.The left ventricle ejection fraction (ef) was 50-55%.Post-op paradoxical interventricular septum.Og slightly dilated.No pah.Undilated straight cavities.Pericardial effusion of low abundance that was localized, 2-3 mm postero-lv, 7-8 mm latero-lv.On (b)(6) 2019, transesophageal echocardiogram (tee) showed non-stenosing but leaking aortic prosthetic with vegetation on the ventricular side opposite the anterior picot (between right and left antero cusp) that was 9mm long filiform at 140°, 6mm at 40° thickening of the posterior cusp by 4-5 mm on the aortic side with severe intra-prosthetic aortic insufficiency due to probable prolapse of the anterior commissure with eccentric jet towards the anterior mitral leaflet vc 6-7mm, pisa 6mm, sub-aortic tvi at 27cm, vmax aortic insufficiency 4.4m/s, aortic vmax at 4.29m/s, g average at 41mmhg (related to aortic insufficiency), and half-decay time 260ms.No ring or mitro aortic trigone abscess was observed; no other valvular involvement was observed.On (b)(6) 2019, the trifecta valve was explanted.Upon explant, a break along one of the uprights of the valve was observed.A new 21mm trifecta valve was successfully implanted as a replacement.In september 2019, there was favorable follow-up with the new trifecta valve.In (b)(6) 2021, the patient passed due to unknown causes.

• Brand Name: SJM TRIFECTA 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: 16817469
• Report Number: 2135147-2023-01837
• Device Sequence Number: 1907269
• Product Code: LWR
• UDI-Device Identifier: 05414734052054
• UDI-Public: 05414734052054
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2017
• Device Model Number: TF-A
• Device Catalogue Number: TF-27A
• Device Lot Number: 5104496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2015
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown