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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 MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 21AJ-501
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Aortic Regurgitation (1716); No Consequences Or Impact To Patient (2199)
Event Date 09/10/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, a 21mm masters valve was implanted in the aortic position.Three months post surgery during a follow-up visit, the patient was confirmed to have severe regurgitation.The physician believed the 21mm valve was inappropriate size for the patient.On (b)(6) 2018, the device was explanted.The patient had elevated differential pressure gradient across the valve during the explant procedure and was administered warfarin to stabilize.The device was successfully replaced with a 23mm masters valve.The patient is reported to be stable.
 
Event Description
It was initially reported that the reported valve was explanted after an implant period of about 3 months.Based on a follow-up conversation with the physician, it was confirmed that this 21mm masters valve was selected for implant, but determined to be the incorrect size so the device was exchanged to complete the procedure.The device was never implanted in the patient.
 
Manufacturer Narrative
An event that the physician chose the improper valve size and did not implant the valve was reported.No damage or other anomalies were found on the valve and there was no evidence of implant, consistent with information from the field.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 mis-sizing event could not be conclusively determined.
 
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Brand Name
SJM MASTERS SERIES MECHANICAL HEART VALVE
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 Key8404483
MDR Text Key138258345
Report Number2648612-2019-00019
Device Sequence Number1
Product Code LWQ
UDI-Device Identifier05414734021104
UDI-Public05414734021104
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 05/15/2019
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 Expiration Date04/30/2019
Device Model Number21AJ-501
Device Catalogue Number21AJ-501
Device Lot Number4590697
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/13/2019
Initial Date FDA Received03/08/2019
Supplement Dates Manufacturer Received04/16/2019
Supplement Dates FDA Received05/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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