MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Aortic Valve Stenosis (1717); Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 05/30/2021

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a patient underwent an implant of a 21 mm sjm trifecta valve on (b)(6) 2016.Four years post implant, degeneration of the trifecta valve was diagnosed.The patient also had a left ventricular ejection fraction (lvef) of 30% and a grade 2 aortic leak.It was determined the patient had "critical" aortic stenosis with left ventricular (lv) dysfunction.The end of (b)(6) 2021 the patient was diagnosed with cardiogenic shock.On (b)(6) 2021,the patient had passed away prior to any surgical intervention.The patient's medical history included but was not limited to hemophilia and renal failure.According to the physician, the patient's comorbidities cannot be excluded as a contributing cause of accelerated deterioration of the patient's condition.No additional information was provided.

Manufacturer Narrative

An event of stenosis, cardiogenic shock, left ventricular dysfunction and patient death was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• MDR Report Key: 12436007
• MDR Text Key: 270202948
• Report Number: 3014918977-2021-00064
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2018
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 5488385
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death