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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TEHCNOLOGIES, INC. ON-X PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE
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ON-X LIFE TEHCNOLOGIES, INC. ON-X PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE Back to Search Results
Model Number ONXACE
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/05/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Valve found to function per specs.The leaflet malfunction was the result of external interference with leaflet motion, not from a defect within the valve.Review of the device history record showed the valve was built per specifications.(b)(4).
 
Event or Problem Description
After implant of the prosthetic aortic valve, and after patient was taken off the bypass, transesophageal echo (tee) was used to verify proper function of the valve.A large pressure gradient was observed along with observing that a leaflet was not moving properly.The on-x valve was explanted and replaced to complete the surgery.The on-x valve was returned for product evaluation.
 
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Brand Name
ON-X PROSTHETIC HEART VALVE
Common Device Name
MECHANICAL HEART VALVE
Manufacturer (Section D)
ON-X LIFE TEHCNOLOGIES, INC.
1300 e. anderson ln
bldg b
austin TX 78752
MDR Report Key5621294
Report Number1649833-2016-70024
Device Sequence Number16155532
Product Code DYE
UDI-Device Identifier00851788001464
UDI-Public00851788001464
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P000037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 04/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date07/20/2016
Device Model NumberONXACE
Device Catalogue NumberONXACE-23
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2016
Initial Report FDA Received Date04/29/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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