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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; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Device Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problems Thrombus (2101); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
On (b)(6) 2020, an unknown mechanical heart valve that was explanted for an unknown reason was received.No additional information was provided and initial reporter is unknown.
 
Manufacturer Narrative
Explant was reported due to an unknown cause.The investigation found that the mechanical leaflets opened and closed completely and easily.A fragment of organizing thrombus was present on a remnant of the sewing cuff.No inflammation or significant calcifications were present.The cause of the reported event could not be conclusively determined.
 
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Brand Name
SJM 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 Key10864264
MDR Text Key217201040
Report Number2648612-2020-00124
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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