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

Model Number CVD0027

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Event Description

On (b)(6) 2010, a 25mm trifecta valve was implanted.On an unknown date, the patient presented with endocarditis.The patient was given antibiotics and on (b)(6) 2018, the event was resolved.Additional information has been requested.(clinical study patient id: (b)(6)).

Manufacturer Narrative

Additional information received about event.Event description updated and information confirmed the endocarditis was resolved with treatment & the valve remains implanted.

Event Description

On (b)(6) 2010, a 25mm trifecta valve was implanted.On (b)(6) 2018, the patient presented with endocarditis.The patient was given antibiotics and the event was resolved.The patient did not have a history of endocarditis.The patient did not undergo any recent dental procedures or injury from a non-sterile object.Per site, endocarditis was not related to the device.The patient is reported discharged.(clinical study patient id: (b)(6).

Manufacturer Narrative

An event of endocarditis was reported.The results of the investigation are inconclusive since the device remains implanted 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, per the site, the endocarditis was not related to the device and the event resolved with antibiotics.

• Brand Name: TRIFECTA STENTED TISSUE 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
• MDR Report Key: 8122890
• MDR Text Key: 129019528
• Report Number: 3008452825-2018-00397
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention