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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 31MECJ-502
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Mitral Regurgitation (1964)
Event Date 02/07/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, a 31mm masters valve was selected for implant.The device was implanted but severe mitral regurgitation was observed via tee.The patient was placed back on bypass.The valve was inspected and confirmed there was no subvalvular obstruction or any hindrances to the leaflets.The device was explanted and replaced successfully with a 31mm carbomedics mechanical heart valve.The patient remained hemodynamically stable despite the bypass time being prolonged.
 
Manufacturer Narrative
The reported event of regurgitation could not be confirmed.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event remains unknown.
 
Event Description
On (b)(6) 2019, a 31mm masters valve was selected for implant.The device was implanted but severe mitral regurgitation was observed via tee.The patient was placed back on bypass.The valve was inspected and confirmed there was no subvalvular obstruction or any hindrances to the leaflets.The device was explanted and replaced successfully with a 31mm carbomedics mechanical heart valve.The patient remained hemodynamically stable despite the bypass time being prolonged by 90 minutes.
 
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Brand Name
SJM MASTERS SERIES VALVE EXPANDED CUFF
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
MDR Report Key8463914
MDR Text Key140288804
Report Number2648612-2019-00016
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier05414734006613
UDI-Public05414734006613
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,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/26/2023
Device Model Number31MECJ-502
Device Lot Number6338326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age26 YR
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