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

Model Number TF-19A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 11/27/2017

Event Type  Injury  

Event Description

(b)(6) 2012, a 19mm trifecta valve was implanted.It was reported that the valve gradient was 100mm/hg in this 4 year old post-implant, on (b)(6) 2017, the valve was explanted and an edwards inspiris resilia valve was implanted.Per report, hospital pathology will retain the valve for analysis and its return to abbott is unconfirmed.The initial surgery was performed at the non-reporting center where the patient is now receiving care.Patient information is not available for this event , due to data protection act.

Manufacturer Narrative

An event of high valve gradient was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2012, a 19mm trifecta valve (sn unknown) was implanted.On (b)(6) 2017, the valve was explanted due to a high valve gradient of 100mm/hg.An edwards inspiris resilia valve was implanted as a replacement.The hospital did not make the trifecta valve available for return.The initial surgery was performed at a facility other than the center where the redo procedure occurred.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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7143629
• MDR Text Key: 95661254
• Report Number: 3008452825-2017-00343
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention