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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL
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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 25MECJ-502
Device Problem Biocompatibility (2886)
Patient Problem Thrombosis (2100)
Event Date 10/16/2019
Event Type  Injury  
Event Description
On (b)(6) 2010, a 25mm carpentier-edwards perimount valve was implanted in the mitral position.On (b)(6) 2019, the non-abbott valve was explanted due to calcification and a 25mm sjm masters series valve expanded cuff was implanted.Two months later, on (b)(6) 2019, a re-do mvr was performed due to thrombosis on the valve.It was replaced with a 23mm magna mitral ease (by edwards lifesciences, serial: unknown).The patient was prescribed (b)(4) and will follow up with regular check-ins.
 
Event Description
On (b)(6) 2010, a 25mm carpentier-edwards perimount valve was implanted in the mitral position.On (b)(6) 2019, the non-abbott valve was explanted due to calcification and a 25mm sjm masters series valve expanded cuff was implanted.Two months later, on (b)(6) 2019, a re-do mvr was performed due to thrombosis on the valve.It was replaced with a 23mm magna mitral ease (by edwards lifesciences, serial: unknown).The patient was prescribed warfarin and will follow up with regular check-ins.Details regarding the patient's anticoagulation therapy was unknown.
 
Manufacturer Narrative
Explant was reported due to thrombus.The investigation found that there was limited mobility of the leaflets.Thrombus was present in both the recessed pivot areas and on the sewing cuff.There were entrapped leukocytes within the thrombus, however no true inflammation 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 thrombus present in the recessed pivot areas would limited the mobility of the leaflets.
 
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Brand Name
SJM MASTERS SERIES VALVE EXPANDED 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 Key9307077
MDR Text Key166967414
Report Number2648612-2019-00094
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 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/23/2022
Device Model Number25MECJ-502
Device Catalogue Number25MECJ-502
Device Lot Number6181309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Was the Report Sent to FDA? No
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
Patient Weight30
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