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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

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ST. JUDE MEDICAL SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 25MECJ-502
Device Problem Obstruction of Flow (2423)
Patient Problem Thrombus (2101)
Event Date 03/13/2019
Event Type  Injury  
Event Description
On (b)(6) 2016, a 25mm masters valve was implanted in the mitral position.On (b)(6) 2019, the device was explanted.Upon explant it was observed one leaflet was obstructed and not functioning as expected and thrombus was observed.The patient was reported to have been compliant with their anticoagulation medication.Subsequently another 25mm valve was implanted.The patient is reported to be stable postoperatively.
 
Manufacturer Narrative
The reported event of "one leaflet was obstructed and not functioning as expected" and thrombus could not be confirmed.Both leaflets opened and closed completely and without resistance.There was fibrous pannus ingrowth limited to the sewing cuff.No inflammations or significant calcifications 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 leaflet obstruction and thrombus could not be conclusively determined.
 
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Brand Name
SJM MASTERS SERIES VALVE EXPANDED CUFF
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ST. JUDE MEDICAL
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
MDR Report Key8492856
MDR Text Key141242259
Report Number2648612-2019-00023
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier05414734006347
UDI-Public05414734006347
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 06/25/2019
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 Expiration Date05/10/2021
Device Model Number25MECJ-502
Device Lot Number5503793
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2019
Initial Date FDA Received04/08/2019
Supplement Dates Manufacturer Received05/31/2019
Supplement Dates FDA Received06/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age32 YR
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