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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXAAP-25
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Distress (2329); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Event Description
Patient is experiencing an extremely loud noise that is vibrating up his neck and shoulders.It is not just the sound it is a pounding.It has been almost 8 weeks from surgery and blood pressures have been 120's/70-80's.This is causing insomnia and distress.
 
Manufacturer Narrative
A review of the available information was performed.The manufacturing records for the onaap-25 sn [serial number] (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.Onxaap-25 sn (b)(4) was implanted (b)(6) 2018 in a 54-year old male.The spouse writes that 8-weeks postop the patient "is experiencing an extremely loud noise that is vibrating up his neck and shoulders." his blood pressure has been measured as 120's/70-80's.This noise is causing insomnia and distress.This is not a complaint about the functionality of the on-x aap valve.It is a quality of life (qol) issue based upon the noise generated by the aap device.The sound generated by the mechanical prosthesis is not unknown, but measuring its intensity, and particularly, its psychoacoustic effect on patients is rarely documented.What is known is that mechanical valve noise is not unique to the on-x valve [nielsen 2005], not even to the valved conduit model [golczyk 2010].But how it affects the patient and his/her companions is less predictable.Patient anatomy plays a part [nielsen 2005], as does the patient's attitude which can change over time [oterhals 2013], perception of the sound [johansen 2000], and adjustment to the new experience [korteland 2016].It is recognized that the on-x aap model makes noise that, in this case, negatively affects the patient's level of comfort.It is unknown what additional contribution the conduit has to the generation of such noise but is noteworthy because of the description of the complainant: ".Extremely loud noise that is vibrating up his neck and shoulders." with a reported normal blood pressure, this seems unusually high.Noise generated by the on-x model aap affects this patient's quality of life, though it remains physiologically functional.Noise generated by the mechanical valve prosthesis is not unique to the on-x brand, nor the conduit model.No further action necessary.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.
 
Event Description
Patient is experiencing an extremely loud noise that is vibrating up his neck and shoulders.It is not just the sound it is a pounding.It has been almost 8 weeks from surgery and blood pressures have been 120's/70-80's.This is causing insomnia and distress.
 
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Brand Name
ON-X ASCENDING AORTIC PROSTHESIS
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 Key7990675
MDR Text Key124529358
Report Number1649833-2018-00159
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,other
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2022
Device Model NumberONXAAP-25
Was Device Available for Evaluation? No
Distributor Facility Aware Date09/24/2018
Date Manufacturer Received09/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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