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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC UNKNOWN CONFIGURATION; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXA UNK
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)
Event Date 05/21/2021
Event Type  Injury  
Event Description
According to the initial report, patient in the (b)(6) study experienced a stroke or transient ischemic attack (tia) which was assessed to be related to the on-x valve.Patient's last inr (b)(6) 2021) was 2.1.Participant was randomized to apixaban 5mg bid on (b)(6) 2021 so no other inrs reported.The on-x valve was implanted on (b)(6) 2018, isolated aortic valve replacement with the on-x valve, size 21 mm.
 
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Brand Name
ON-X AORTIC 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.
kenessaw, GA 30144
7704193355
MDR Report Key12016442
MDR Text Key256711005
Report Number1649833-2021-00023
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,study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberONXA UNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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