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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 19; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC STANDARD EXT 19; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXAE-19
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Aortic Valve Stenosis (1717)
Event Date 11/05/2020
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Event Description
According to the initial report, onxae-19 sn (b)(4) was implanted on (b)(6) 2007 and explanted on (b)(6) 2020 due to aortic stenosis."aortic stenosis with vp 3.8m/s, maxpg 58mmhg was recognized.However, during the operation, none of the possible cause such as pannus or thrombus which indicates any contribution of the acceleration of blood flow was observed.No infection was detected / 153cm, 51kg, bsa 1.5m2".
 
Event Description
According to the initial report, onxae-19 sn (b)(6) was implanted on (b)(6) 2007 and explanted on (b)(6) 2020 due to aortic stenosis."aortic stenosis with vp 3.8m/s, maxpg 58mmhg was recognized.However, during the operation, none of the possible cause such as pannus or thrombus which indicates any contribution of the acceleration of blood flow was observed.No infection was detected/153cm, 51kg, bsa 1.5m2.".
 
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Brand Name
ONX AORTIC STANDARD EXT 19
Type of Device
HEART-VALVE, MECHANICAL
Manufacturer (Section D)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
MDR Report Key11137550
MDR Text Key225770318
Report Number1649833-2021-00002
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/01/2011
Device Model NumberONXAE-19
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date12/11/2020
Date Manufacturer Received12/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
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