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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE UNKNOWN SIZE; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE UNKNOWN SIZE; HEART-VALVE, MECHANICAL Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem No Code Available (3191)
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 initial reports, about 18 months ago the surgeon inserted an on-x aortic in a patient and despite best efforts and apparent good compliance of the patient the inrs fluctuate widely from 0,8 to 8,0 and most inrs are out of the therapeutic range of 1,5 to 2,0.
 
Manufacturer Narrative
A review of the available information was performed."according to initial reports, about 18 months ago the surgeon inserted an on-x aortic valve in a patient and despite best efforts and apparent good compliance of the patient the inrs fluctuate widely from 0.8 to 8.0 and most inrs are out of the therapeutic range of 1.5 to 2.0 and the physician is unable to control it." recommended anticoagulation for the onxa valve only refers to "adequate anticoagulation" with selection based upon "the particular needs of the patient, the clinical situation, and established professional guidelines." patients with an on-x valve in the aortic valve position should be maintained on long-term warfarin anticoagulation which should achieve an international normalized ratio (inr) of 2.0 - 3.0 for the first 3 months after valve replacement surgery, after which the inr should be reduced to 1.5 - 2.0.[instructions for use].There is no indication or suggestion that the inability to manage the patient's inr is in any way related to the presence of the onxa other than the fact that all mechanical valve recipients are recommended anticoagulant therapy of warfarin and aspirin unless medically contraindicated.[nishimura, et al.2016].No adverse events related to the inr instability despite patient compliance have been reported.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu (instructions for use).Based on the limited available information, a definitive root cause for this event cannot be determined.No further action is warranted at this time.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
According to initial reports, about 18 months ago the surgeon inserted an on-x aortic in a patient and despite best efforts and apparent good compliance of the patient the inrs fluctuate widely from 0,8 to 8,0 and most inrs are out of the therapeutic range of 1,5 to 2,0.
 
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Brand Name
ON-X AORTIC VALVE UNKNOWN SIZE
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 Key8069144
MDR Text Key127130150
Report Number1649833-2018-00166
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 company representative,foreig
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Distributor Facility Aware Date10/18/2018
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Other;
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