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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 31MJ-501
Device Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2019
Event Type  Injury  
Event Description
On (b)(6) 2019, a 31mm masters valve was implanted in the mitral position.Post procedure after closing the chest, the physician observed that one of the leaflets was not moving properly.The chest was reopened and the physician explanted the 31mm masters valve.A 29mm masters valve was successfully implanted.The patient is reported to be stable.
 
Event Description
On (b)(6) 2019, a 31mm masters valve was implanted in the mitral position.Post procedure after closing the chest, the physician observed that one of the leaflets was not moving properly.The chest was reopened and the physician explanted the 31mm masters valve.A 29mm masters valve was successfully implanted.The patient is reported to be stable.
 
Manufacturer Narrative
An event of one of the leaflets not moving properly 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 and the product met all specifications at the time of commercialization.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 could not be conclusively determined.
 
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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 Key8561968
MDR Text Key143457004
Report Number2648612-2019-00032
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier05414734006620
UDI-Public05414734006620
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,health
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/09/2019
Device Model Number31MJ-501
Device Catalogue Number31MJ-501
Device Lot Number4605183
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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