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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE
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ON-X LIFE TECHNOLOGIES, INC. ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE Back to Search Results
Model Number ONXACE
Device Problem Interference (1327)
Patient Problems Aortic Valve Stenosis (1717); Dyspnea (1816); Stroke (2086); Thrombosis (2100)
Event Date 07/03/2014
Event Type  Injury  
Event Description
Valve thrombosis of tne on-x aortic valve prosthesis, post-operative (late), an expected adverse event for a mechanical heart valve, occurring well-within expected frequency (0.01 percent/ptyr), and is valve-related per definitions in the aats/sts guidelines.Therefore, it is being reported.Patient had a stroke on arrival at hospital, severe valve stenosis, and echo-detected thrombus interfering with leaflet motion.Inr on admission was 2.0, judged to be "subtherapeutic".Re-operated, previous avr explanted and replaced.
 
Manufacturer Narrative
Thrombus confirmed by visual inspection.Leaflet mition blocked by thrombus.
 
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Brand Name
ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE
Type of Device
MECHANICAL HEART VALVE
Manufacturer (Section D)
ON-X LIFE TECHNOLOGIES, INC.
8200 cameron rd., a-196
austin TX 78754
Manufacturer Contact
walt moeller, director
1300 e. anderson ln
bldg. b
austin, TX 78752
5123398000
MDR Report Key4152413
MDR Text Key4930240
Report Number1649833-2014-00009
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 User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/22/2017
Device Model NumberONXACE
Device Catalogue NumberONXACE-21
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/01/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/10/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age65 YR
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