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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE (UNKNOWN); HEART-VALVE, MECHANICAL Back to Search Results
Device Problems Calcified (1077); Patient Device Interaction Problem (4001)
Patient Problem Thrombus (2101)
Event Date 12/05/2019
Event Type  Injury  
Event Description
On (b)(6) 2008, a unknown mechanical heart valve was implanted.On (b)(6) 2019, the valve was explanted.The leaflet of the valve was restricted due to thrombus formation.The valve was replaced with a 23mm magna ease valve.No additional information was provided.
 
Manufacturer Narrative
Explant was reported due to leaflet movement being restricted by thrombus formation.The investigation found that there was slightly limited mobility of one leaflet.Thrombus was present in one recessed pivot area.Calcifications were present on the sewing cuff.No inflammation was present.The thrombus found in the recessed pivot area could have restricted the mobility of the leaflet.
 
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Brand Name
SJM MECHANICAL HEART VALVE (UNKNOWN)
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 Key9541773
MDR Text Key176030681
Report Number2648612-2020-00001
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,health
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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