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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE
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ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE Back to Search Results
Model Number ONXM
Device Problem Device remains implanted (1526)
Patient Problems Stroke (2086); Thrombus (2101)
Event Date 07/12/2014
Event Type  Injury  
Event Description
Patient has on-x mitral valve replacement (mvr) done on (b)(6) 2014 re-admitted to hospital on (b)(6) 2014 after a stroke.Echo showed possible thrombus formation on leaflets, however, the valve remains functional and remains implanted.
 
Manufacturer Narrative
The device remains functional and implanted.It is not available for investigation.Could not get serial number information.
 
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Brand Name
ON-X MITRAL PROSTHETIC HEART VALVE
Type of Device
MECHANICAL HEART VALVE
Manufacturer (Section D)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln
bldg b.
austin TX 78752
Manufacturer Contact
walt moeller, director
1300 e. anderson ln
bldg b
austin, TX 78752
5123398000
MDR Report Key4036567
MDR Text Key15810091
Report Number1649833-2014-00010
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberONXM
Device Catalogue NumberONXM-31/33
Other Device ID NumberNOT YET ESTABLISHED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age39 YR
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