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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

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ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 25AGFN-756
Device Problems Perivalvular Leak (1457); Biocompatibility (2886)
Patient Problem Endocarditis (1834)
Event Type  Injury  
Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
 
Event Description
On an unknown date an abbott mechanical heart valve was implanted.On (b)(6) 2020, the valve was explanted for infective endocarditis of aortic valve prosthesis with a root abscess leading to a paravalvular leak.Patient status is unknown.Additional information was requested but has not be obtained at this time.
 
Manufacturer Narrative
Additional information: d10 h3, h6.Explant was reported due to infective endocarditis and endocarditis of the valve prosthesis.The investigation found that the mechanical leaflets opened and closed completely and easily.There was minimal pannus formation on the sewing cuff.In addition to the valve, separate fragments of myocardium were also received, which had areas of necrosis.No inflammation or significant areas of calcification were present.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.The cause of the reported event could not be conclusively determined.
 
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Brand Name
SJM REGENT HEART VALVE W/FLEX CUFF
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 Key9716325
MDR Text Key179612012
Report Number2648612-2020-00012
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,foreig
Type of Report Initial,Followup
Report Date 04/27/2020
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
Device Expiration Date10/08/2013
Device Model Number25AGFN-756
Device Catalogue Number25AGFN-756
Device Lot Number2717659
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/17/2020
Supplement Dates Manufacturer Received04/24/2020
Supplement Dates FDA Received04/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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