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

Model Number TF-21A

Device Problem Calcified (1077)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of calcification could not be confirmed.High gradient was also reported.The results of the investigation are inconclusive since the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, calcification is a known event associated with tissue heart valves and is consistent with the reported high gradient.Information from the field indicated the valve had been implanted for over 8 years.

Event Description

On (b)(6) 2010, a 21mm trifecta valve was implanted.On an unknown date the patient developed high gradient and calcification was identified.On (b)(6) 2018, a portico valve was implanted in the trifecta valve.The patient is reported to be stable.

Event Description

On (b)(6) 2010, a 21 mm trifecta valve was implanted.On (b)(6) 2018, the patient developed high gradient and calcification was identified.On (b)(6) 2018, a valve in valve procedure was planned.On (b)(6) 2018, a non-abbott tavi valve was implanted in the trifecta valve.The patient is reported to be stable.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8177104
• MDR Text Key: 130763736
• Report Number: 3007113487-2018-00029
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2012
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 3133681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2010
• 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): Hospitalization; Required Intervention