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 Perivalvular Leak (1457)

Patient Problems Fever (1858); Pleural Effusion (2010); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

Gtin -- unknown, lot number not provided the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

According to the article "redo mitral valve replacement via right thoracotomy for mitral paravalvular leaks induced by infections endocarditis in patient with prior mitral valve replacement and coronary bypass grafting�heart's original, 2016, vol.48, no.5 pp.528-533), a 25mm mechanical heart valve was implanted in the mitral position on an unknown date secondary to mitral regurgitation (mr) caused by infective endocarditis (ie).Concomitantly, coronary artery bypass grafting (cabg) was performed between the left internal thoracic artery (lita) and left anterior descending coronary artery (lad).Approximately six months post-implant, the patient presented with a fever and was admitted for evaluation.A transesophageal echo (tee) revealed prolapse of the valve on the anterolateral commissure side of the patient's native annulus, significant mr and vegetation-like material on the mitral annulus.A blood culture was negative.After 16 days of antibiotics, the patient's regimen was interrupted due to a decreased platelet count; however, the patient presented with a recurring high fever and a different antibiotic was prescribed.A chest x-ray revealed pulmonary congestion and pleural effusion with a cardiothoracic rate (ctr) of 62%.An echocardiography revealed an ejection fraction (ef) of 55%, left ventricle diastolic dimension (lvdd) of 51mm, a left ventricular end-systolic diameter (lvesd) of 34mm, left ventricular end-diastolic volume (lvedv) of 116ml and left ventricular end-systolic volume (lvesv) of 52ml.A coronary cat was performed and revealed all three cabgs (lita-lad, svg-pl and svg-4pd) were completely patented.A thoracic cat revealed significant arteriosclerosis between the ascending aorta and aortic arch.As the patient developed cardiac insufficiency due to mr caused by suspected ie which did not respond to medication, surgery was scheduled.Approximately nine months post-implant, a redo mvr was performed via right thoractomy under ventricular fibrillation (vf) and the valve was explanted.Ex vivo, approximately one-third of the valve was found prolapsed from the patient's native annulus and a paravalvular leak was observed.The patient's annular tissue was disrupted near the prolapsed area around the anterolateral commissure but the remaining annular tissue appeared to be strong.No evidence of infection or vegetation was observed.Both the anterior and posterior cusps of the patient's native mitral valve were confirmed to be resected at the time of the previous mvr.A second 25mm mechanical heart valve was implanted in the supra-annular position.Postoperatively, continuous hemodiafiltration (chdf) and hemodialysis (hd) were conducted for hemocatharsis.Then the patient's dry weight was slightly reduced until preoperative value and antibiotic was administered.Approximately seven weeks post-redo procedure, the patient was transferred to another hospital for rehabilitation and was eventually discharged in stable condition.

• 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: 5722531
• MDR Text Key: 47298301
• Report Number: 2648612-2016-00053
• 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: Physician
• Type of Report: Initial
• Report Date: 06/09/2016

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: Physician
• Device Model Number: 25MJ-501
• Device Catalogue Number: 25MJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 06/14/2016
• 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
• Patient Age: 65 YR