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

Model Number TF-21A

Device Problem Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Cardiac Tamponade (2226); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/28/2018

Event Type  Death  

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 26 september 2011, a 21mm trifecta valve was implanted during an aortic valve replacement.On (b)(6) 2018, the patient was hospitalized due to cardiac decompensation, specifically cardiac failure with orthopnea without angina.On (b)(6) 2018, the valve was explanted due to degeneration, and the patient also required revascularization procedure due to stenosis at left main artery and circumflex artery.On echocardiogram, there was good systolic function at the left ventricle.The valve had stenosis with a gradient of 40mmhg and maximum velocity of 4.2m/s.The valve was replaced with a 19mm trifecta valve with no reported issues during valve replacement.Post-procedure, lactate increase was noted, and patient had sudden post-operative state of shock.A post-operative pericardial tamponade was observed on echocardiogram.Patient went into multi-organ failure.A colonoscopy was performed due to digestive ischemia, and the colon was perforated due to complications during the procedure.On 31 may 2018, the patient passed away.An autopsy was not performed.The cause of death was linked to the surgical revision, but no clear etiology was determined.No additional information was provided.

Manufacturer Narrative

As reported in a research article, about 6 and a half years after the device was implanted the valve was explanted due to degeneration of the valve and stenosis.It was also reported that the patient passed away three days later, with the death being linked to the surgical revision.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 cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Na.

• 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 PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16811677
• MDR Text Key: 313985489
• Report Number: 2135147-2023-01824
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3466030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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): Death
• Patient Age: 74 YR
• Patient Sex: Female