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

Model Number TF-19A

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problem Chest Pain (1776)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2010, a 19mm trifecta valve was implanted.On an unknown date in (b)(6) 2019, the patient was hospitalized for angina.An echocardiogram was performed and valve degeneration with calcification and high gradient was noted.On (b)(6) 2019, the trifecta valve was explanted and replaced with a 19mm magna ease.Following the implant of the magna ease there was a hemodynamic deterioration and a cardiac massage was performed and ecmo (extracorporeal membrane oxygenation) was installed.Patient is reported to be stable.

Manufacturer Narrative

An event of angina, valve degeneration, calcification, and high gradient was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.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: 8878852
• MDR Text Key: 153824772
• Report Number: 3007113487-2019-00022
• Device Sequence Number: 1
• Product Code: LWR
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2012
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3181789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR