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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 21; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ONX ASCENDING AORTIC 21; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXAAP-21
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Aortic Dissection (2491)
Event Date 11/15/2018
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 an email received on (b)(6) 2018: "received irc serial number for patient that received a valve on (b)(6) 2017 for same position- [same type valve and different serial number]".A phone call was made in attempt to reach the complainant on 12/03/2018.The working staff received the call and stated the doctor was not available.When asked information regarding the use of the explanted valve and if any deficiency was noted, the working staff stated: "according to the operative notes the patient was experiencing arrhythmia.When the valve was explanted, no issue was noted with the valve.Which isn't too surprising considering the patient has quite a few issues for one so young".Operative notes were asked for and the staff replied, "i cannot give you that information.I can say that the problem was not the valve and that another one of your valves was implanted.Should we have any issue we would report it accordingly".
 
Manufacturer Narrative
A review was held of the available information.Arrhythmia and reoperation are recognized potential complications following aortic valve replacement surgery, but there is not enough detailed information to establish a root cause for the arrhythmia or explant.Based on the available information there is no indication that the events were valve related.The product met all specifications prior to release and the working staff stated: ¿no issue was noted with the valve.¿ a definitive root cause for the reported event is unknown.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications including arrhythmia and explant.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).No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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 an email received on (b)(6)2018: "received irc serial number for patient that received a valve on (b)(6)2017 for same position- [same type valve and different serial number]." a phone call was made in attempt to reach the complainant on (b)(6)2018.The working staff received the call and stated the doctor was not available.When asked information regarding the use of the explanted valve and if any deficiency was noted, the working staff stated: "according to the operative notes the patient was experiencing arrhythmia.When the valve was explanted, no issue was noted with the valve.Which isn't too surprising considering the patient has quite a few issues for one so young." operative notes were asked for and the staff replied, "i cannot give you that information.I can say that the problem was not the valve and that another one of your valves was implanted.Should we have any issue we would report it accordingly.".
 
Manufacturer Narrative
A review was held of the available information.Arrhythmia and reoperation are recognized potential complications following aortic valve replacement surgery, but there is not enough detailed information to establish a root cause for the arrhythmia or explant.Based on the available information there is no indication that the events were valve related.The product met all specifications prior to release and the working staff stated: ¿no issue was noted with the valve.¿ a definitive root cause for the reported event is unknown.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications including arrhythmia and explant.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).No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.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 an email received on 11/29/2018: "received irc serial number for patient that received a valve on aug 8, 2017 for same position- [same type valve and different serial number]." a phone call was made in attempt to reach the complainant on 12/03/2018.The working staff received the call and stated the doctor was not available.When asked information regarding the use of the explanted valve and if any deficiency was noted, the working staff stated: "according to the operative notes the patient was experiencing arrhythmia.When the valve was explanted, no issue was noted with the valve.Which isn't too surprising considering the patient has quite a few issues for one so young." operative notes were asked for and the staff replied, "i cannot give you that information.I can say that the problem was not the valve and that another one of your valves was implanted.Should we have any issue we would report it accordingly.".
 
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Brand Name
ONX ASCENDING AORTIC 21
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 Key8187103
MDR Text Key131135385
Report Number1649833-2018-00179
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 user facility
Type of Report Initial,Followup,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberONXAAP-21
Was Device Available for Evaluation? No
Date Manufacturer Received11/29/2018
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age29 YR
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