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

Model Number TF-23A

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

An event of endocarditis and tissue growth 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; however, the author of the article suspected the source of infective endocarditis was a mouth infection because the patient's gums bled when brushing their teeth.

Event Description

The following information comes from the abstract of the "japanese journal of medical ultrasound technology", 2018 june, vol.43 supplement, page s147, 43-9.(available only in japanese) title: a case of infective endocarditis after aortic valve replacement.On an unknown date, approximately one year and a half ago, a 23mm trifecta valve (serial unknown) was implanted in a male septuagenarian patient's aortic position.On an unknown date, the patient had a fever and was admitted to a hospital.No abnormal findings were observed through transthoracic echocardiography (tte).On day 5 of admission, vegetation was confirmed on the valve.As streptococcus.Mitis was detected by blood culture, the patient was diagnosed with infective endocarditis (ie).An increased inflammatory response was confirmed with a white blood cell (wbc) of 14,130/ul and c-reactive protein (crp) of 5.88mg/dl.A repeated tte was performed and an 18 x 8 mm sized mobile substance was found at the commissure on this valve, which was located in the middle position.Another tee observed abnormal structure like vegetative mass close to the commissure of the non-coronary cusp (ncc), which was mobile and measured 26 x 9 mm.A small mass was also located on the left coronary cusp (lcc).Antibiotic therapy was started; however, it was not effective enough so surgical intervention was required.Upon explant of this valve, an approximately 20mm sized vegetation was adhered on the ncc and another vegetation was adhered on the inflow side of the lcc.Another prosthetic valve (size and model unknown) was implanted.The postoperative course was uneventful and the inflammatory response turned negative.The patient was discharged from the hospital without recurrence of ie.The author believes the source of infective endocarditis was through a mouth infection.The patient did not have history of teeth or cavity problems, but the patient had been brushing their teeth until the gums would bleed.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7886697
• MDR Text Key: 120693775
• Report Number: 3008452825-2018-00317
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TF-23A
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/18/2018
• 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): Hospitalization; Required Intervention