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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 21A-101
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Corneal Pannus (1447); Aortic Valve Stenosis (1717)
Event Date 05/29/2019
Event Type  Injury  
Event Description
On (b)(6) 1991, a 21mm sjm mechanical heart valve was implanted in the aortic position and a mvr procedure was performed concomitantly.Leaflet mobility was reported to be restricted due to circumferential pannus formation and aortic stenosis.On (b)(6) 2019, the valve was explanted and a 19mm trifecta gt valve was implanted.
 
Manufacturer Narrative
An event of restricted leaflet mobility could not be confirmed.Hydrodynamic testing upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.Information form the field indicated that the leaflet was restricted due to circumferential pannus formation and aortic stenosis.
 
Event Description
On (b)(6) 1991, a 21mm sjm mechanical heart valve was implanted in the aortic position and a mvr procedure was performed concomitantly.Leaflet mobility was reported to be restricted due to circumferential pannus formation and aortic stenosis.On (b)(6) 2019, the valve was explanted and a 19mm trifecta gt valve was implanted.
 
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Brand Name
SJM MECHANICAL HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
177 east county road b
st. paul MN 55117
MDR Report Key9157292
MDR Text Key161966046
Report Number3007113487-2019-00029
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 foreign
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number21A-101
Device Catalogue Number21A-101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient Weight45
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