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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL CATD SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 27A-101
Device Problem Incomplete Coaptation (2507)
Patient Problem Regurgitation (2259)
Event Date 08/05/2019
Event Type  Injury  
Manufacturer Narrative
The investigation results will be provided in a subsequent submission.
 
Event Description
On (b)(6) 1987, a 27mm mechanical heart valve was implanted.Since (b)(6) 2017, regurgitation had been observed by echo and ejection fraction value had decreased slowly, from 60% down to 50% and then 30%.On (b)(6) 2019, the device was explanted and a 25mm master's valve was successfully implanted.Upon explant, no pannus formation, thrombus or calcification were observed on the device.The patient was stable throughout the procedure and post-operatively.
 
Manufacturer Narrative
The valve was reportedly explanted due to regurgitation, approximately 32 years after implant.The suspected incomplete coaptation could not be confirmed.The mechanical leaflets were able to open and close completely and easily.A thin layer of partially detached tissue was found on a small portion of the orifice rim.This tissue did not extend into the inner diameter of the valve.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 root cause of the regurgitation could not be conclusively determined.
 
Event Description
On (b)(6) 1987, a 27mm mechanical heart valve was implanted.Since (b)(6) 2017, regurgitation had been observed by echo and ejection fraction value had decreased slowly, from 60% down to 50% and then 30%.On (b)(6) 2019, the device was explanted and a 25mm master's valve was successfully implanted.Upon explant, no pannus formation, thrombus or calcification were observed on the device.The patient was stable throughout the procedure and post-operatively.Additional information requested.
 
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Brand Name
SJM MECHANICAL HEART VALVE
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL CATD
4 robbins drive
westford MA 01886
MDR Report Key8947026
MDR Text Key156035666
Report Number2126673-2019-00001
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 foreign
Type of Report Initial,Followup
Report Date 10/15/2019
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 Model Number27A-101
Device Catalogue Number27A-101
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/06/2019
Initial Date FDA Received08/29/2019
Supplement Dates Manufacturer Received09/20/2019
Supplement Dates FDA Received10/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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