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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. (CS) SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL

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ST. JUDE MEDICAL PUERTO RICO, INC. (CS) SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 25MECJ-502
Device Problem Gradient Increase (1270)
Patient Problems Death (1802); Dyspnea (1816); Thrombus (2101); Low Cardiac Output (2501)
Event Date 08/27/2015
Event Type  Death  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
On (b)(6) 2014, a 25mm masters series mechanical heart valve was implanted.On (b)(6) 2015, the patient reported dyspnea and presented with an inr of 4.3.Tte revealed a peak gradient of 64mm hg and a mean gradient of 30mm hg, an impeded mitral valve and an emergency mitral valve replacement (mvr) was performed.At surgery, a large thrombus was found inside the valve.Redo mvr was performed; however the patient expired (b)(6) 2015 day due to severe low cardiac output.Per report, the patient had been compliant with anti-coagulation therapy following the 2014 implant.Between (b)(6) 2015, the patient's inr ranged from 2.2-2.65.
 
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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. (CS)
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
p.o. box 998
lot 20 b st.
caguas, puerto rico 00725
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key5081454
MDR Text Key25965781
Report Number2648612-2015-00021
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P810002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Report Date 09/01/2015
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 No Information
Device Expiration Date11/18/2018
Device Model Number25MECJ-502
Device Catalogue Number25MECJ-502
Device Lot Number4350945
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/16/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age46 YR
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