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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXACE-23
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
According to the initial report, "[surgeon] said the patient came in for follow up and has high gradients (30 mean and 52 peak).Cath shows both leaflets moving but no opening to 90 degrees.He asked if we could have someone look at the cath clips to see if there is something going on with the valve.".
 
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Brand Name
ON-X AORTIC 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 Key11474591
MDR Text Key240320024
Report Number1649833-2021-00009
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberONXACE-23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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