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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

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ST. JUDE MEDICAL PUERTO RICO, INC. SJM MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number 31M-101
Device Problem Gradient Increase (1270)
Patient Problems Right Ventricular Dysfunction (2054); Thrombus (2101); Regurgitation, Valvular (2335)
Event Date 12/02/2014
Event Type  Injury  
Manufacturer Narrative
(b)(4).The results of this investigation concluded thrombus formation in the recessed pivot area, and both leaflets opened and closed with difficulty with incomplete closure of one of the leaflets.Special stains were negative for organisms, and no acute inflammation or significant calcifications were present.There was no evidence found to suggest the cause of the thrombus formation was due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the fibrin and tears remains unknown.
 
Event Description
A 2d echocardiogram demonstrated a mechanical mitral valve with restricted opening, mild paravalvular regurgitation, elevated gradients, and significant right ventricular dysfunction.The mechanical valve was explanted and replaced with a smaller 27 mm sjm epic tissue valve.At the time of explant, thrombus was observed on the valve.The patient was reported to be stable postoperatively.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
SJM 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 0072 5
Manufacturer (Section G)
ST. JUDE MEDICAL PUERTO RICO, INC.
p.o. box 998
lot 20 b st.
caguas, puerto rico 0072 5
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517565400
MDR Report Key4357997
MDR Text Key13220821
Report Number2648612-2014-00054
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/02/2014
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 Date09/09/2018
Device Model Number31M-101
Device Catalogue Number31M-101
Device Lot Number4239666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/02/2014
Initial Date FDA Received12/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2013
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) Hospitalization; Required Intervention;
Patient Age23 YR
Patient Weight37
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