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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES MECHANICAL HEART VALVE
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ST. JUDE MEDICAL SJM MASTERS SERIES MECHANICAL HEART VALVE Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problems Endocarditis (1834); Organ Dehiscence (2502)
Event Date 01/28/2014
Event Type  Injury  
Event Description
The info provided to sjm indicated a female pt underwent aortic and mitral valve replacement.The mitral valve was replaced with a 27mm sjm master series valve (model # unk, serial # unk).The pt presented with a para-valvular leak as a result of dehiscence.The physician confirmed the pt had endocarditis.On (b)(6) 2014, the leakage was successfully corrected using an amplatzer vascular plug.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device remains implanted.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the info received, the cause of the dehiscence remains unk.However, info from the field indicated the pt had endocarditis.
 
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Brand Name
SJM MASTERS SERIES MECHANICAL HEART VALVE
Manufacturer (Section D)
ST. JUDE MEDICAL
caguas PR
Manufacturer Contact
denise johnson, rn
lot 20 b st.
po box 998
caguas, PR 00725
6517564470
MDR Report Key3724209
MDR Text Key4326437
Report Number2648612-2014-00013
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/28/2014
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 Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/28/2014
Initial Date FDA Received02/21/2014
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 Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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