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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 21; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 21; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXAE-21
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Thromboembolism (2654); Convulsion/Seizure (4406)
Event Date 10/25/2020
Event Type  Injury  
Event Description
According to the initial report, "patient is subject #29 in the on-x post approval study.On (b)(6) 2020: hematuria due to renal stones, fully resolved with medication.On (b)(6) 2020: thromboembolism, neurologic, cva: status epilepticus- mri workup showed multiple small infarcts in bilateral cerebral hemisphere (medical record attached)" this event is relegated to onxae-21 (b)(4).Adjudication determined the hematuria event unrelated to the valve; however, the thromboembolism event was determined to be valve-related.As such, the thromboembolism event will be further investigated.
 
Event Description
According to the initial report, "patient is subject #29 in the on-x post approval study.On (b)(6) 2020: hematuria due to renal stones, fully resolved with medication.On (b)(6) 2020: thromboembolism, neurologic, cva: status epilepticus- mri workup showed multiple small infarcts in bilateral cerebral hemisphere (medical record attached)" this event is relegated to onxae-21 (b)(4).Adjudication determined the hematuria event unrelated to the valve; however, the thromboembolism event was determined to be valve-related.As such, the thromboembolism event will be further investigated.
 
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Brand Name
ONX AORTIC STANDARD EXT 21
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 Key13060844
MDR Text Key285535326
Report Number1649833-2021-00047
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 Study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/22/2022
Device Model NumberONXAE-21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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