MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 25MJ-501

Device Problem Microbial Contamination of Device (2303)

Patient Problem Endocarditis (1834)

Event Type  Injury  

Manufacturer Narrative

An event of endocarditis 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

The following information comes from the article, ¿a case of prosthetic valve endocarditis detected by effective blood culture,¿ which was taken from the journal of ¿japanese journal of intensive care medicine¿ 2018, vol.42, no.1, pp.60-63.In 2007, the patient presented with infective endocarditis (ie) caused by infection of ddd pacemaker and heart failure.A mitral valve replacement (mvr) was performed with a 25mm sjm mechanical heart valve and concomitant left ventricle myomectomy.On (b)(6) 2017, the patient presented with a fractured pubic bone, fever, and increased in c-reactive protein (crp) levels.On (b)(6) 2017, crp levels raised to 13.27 mg/dl and streptococcus oralis and staphylococcus hominis were detected by blood culture.Endocarditis was suspected and the patient was administered minomycin.On (b)(6) 2017, the patient was hospitalized, transthoracic echocardiography and transesophageal echocardiography did not show any mitral regurgitation or vegetation of ie; however, the due to the patient¿s medical history of ie, ampicillin was administered for 6 weeks.On (b)(6) 2017, the patient was discharged.In late (b)(6) of 2017, the patient felt unwell with absence of fever.On (b)(6) 2017, blood culture was conducted and on the following day, (b)(6) was detected.On (b)(6) 2017, the patient was re-admitted to the hospital.Crp was negative, and there was no significant vegetation or disruption of the valve observed.On (b)(6) 2017, a repeated tee revealed a mobile 1cm-sized tumor mass on the valve.The patient was monitored and treated with antibiotics.On (b)(6) 2017, there was a slightly positive reaction of crp with 0.3 mg/dl.As no improvement was observed on tee, a re-do mvr was scheduled.On (b)(6) 2017, the re-do mvr was performed and the valve was explanted.Upon explant, a 1cm-sized vegetation was observed.The valve replaced with a 23mm carpentier-edwards perimount magna ease mitral heart valve.On (b)(6) 2017, the patient was discharged.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7400554
• MDR Text Key: 104531043
• Report Number: 2648612-2018-00028
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 79 YR
• Patient Weight: 45