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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXM UNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Event Description
According to the on-demand abstract "long term data on-x mitral valve", out of 661 patients, surgical mortality was 7,3% (n=41), stroke 7, myocardial infarction 13, permanent pacemaker 2, acute kidney injury 3, postoperative bleeding 16 and length of stay (days) was 16.
 
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Brand Name
ON-X MITRAL 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. nw
kennesaw, GA 30144
7704193355
MDR Report Key11504026
MDR Text Key240319919
Report Number1649833-2021-00010
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberONXM UNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening; Other;
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