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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 27AJ-501
Device Problem Fluid/Blood Leak (1250)
Patient Problems Mitral Regurgitation (1964); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
An event of regurgitation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Information from the field indicated the regurgitation was "due to muscle resection for subaortic stenosis.".
 
Event Description
The information was found in the professional literature of japanese society of pediatric cardiology and cardiac surgery(id#(b)(4)).On an unknown date, a (b)(6) pediatric patient with severe mitral regurgitation was implanted with a 27mm masters valve.Eight years later when the patient was (b)(6), the 27mm masters valve was explanted due to severe mitral regurgitation due to muscle resection for subaortic stenosis.A second 27mm prosthetic heart valve was implanted and a residual ventricular septal defect was confirmed.Twenty years later when the patient was (b)(6), severe mitral regurgitation due to prolapse, pulmonary hypertension, and increased shunt between the ventricles were observed.Leakage was observed at the transvalvular level of the left ventricular outflow tract side and perivalvular leakage was observed adjacent to the left ventricular inferior wall.A third mvr with an unknown valve was performed and concomitant interventricular septum closure (vsd) and atrial septum closure(asd)was performed.
 
Event Description
The information was found in the professional literature of japanese society of pediatric cardiology and cardiac surgery(id# (b)(4).On an unknown date, a 3-year-old pediatric patient with severe mitral regurgitation was implanted with a 27mm masters valve.Eight years later when the patient was 11-years-old, the 27mm masters valve was explanted due to severe mitral regurgitation due to muscle resection for subaortic stenosis.A second 27mm prosthetic heart valve was implanted and a residual ventricular septal defect was confirmed.Twenty years later when the patient was 3years-old, severe mitral regurgitation due to prolapse, pulmonary hypertension, and increased shunt between the ventricles were observed.Leakage was observed at the transvalvular level of the left ventricular outflow tract side and perivalvular leakage was observed adjacent to the left ventricular inferior wall.A third mvr with an unknown valve was performed and concomitant interventricular septum closure (vsd) and atrial septum closure(asd)was performed.The patient had a history of congenital azygos continuation of the inferior vena cava, polysplenia, and atrial ventricle septal defect.
 
Manufacturer Narrative
An event of regurgitation was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Information from the field indicated the regurgitation was "due to muscle resection for subaortic stenosis.".
 
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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
MDR Report Key8072061
MDR Text Key127199353
Report Number2648612-2018-00102
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number27AJ-501
Device Catalogue Number27AJ-501
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age31 YR
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