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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXM-27/229
Device Problems Break (1069); Insufficient Information (3190)
Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)
Event Date 10/01/2021
Event Type  Injury  
Event Description
According to initial reports, leaflet fracture resulting in acute pulmonary oedema due to severe mr and subsequent explant of valve.No evidence of infective endocarditis.
 
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Brand Name
ON-X VALVE UNKNOWN CONFIGURATION
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
Manufacturer (Section G)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
Manufacturer Contact
rochelle maney
1655 roberts blvd
kennesaw, GA 30144
7704193355
MDR Report Key12698470
MDR Text Key278445490
Report Number1649833-2021-00040
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberONXM-27/229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2021
Is the Reporter a Health Professional? No
Distributor Facility Aware Date10/01/2021
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age35 YR
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