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

Model Number TF-25A

Device Problem Insufficient Information (3190)

Patient Problems Mitral Insufficiency (1963); Respiratory Distress (2045); No Code Available (3191)

Event Date 09/09/2014

Event Type  Injury  

Event Description

The patient underwent a mitral and tricuspid valve repair along with an aortic valve replacement procedure and recovered well.An echocardiogram in (b)(6) 2014 revealed aortic valve regurgitation, elevated gradients, and incomplete closure of the cusps.The patient was prescribed a diuretic and trimetazidine hydrochloride and pulmonary function improved.The patient was reported to be in stable condition with shortness of breath during activity.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis as it remains implanted.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.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, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; 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 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 4200463
• MDR Text Key: 4963113
• Report Number: 3008452825-2014-00039
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2013
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 3443969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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
• Patient Age: 82 YR