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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER; HEART-VALVE, MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER; HEART-VALVE, MECHANICAL Back to Search Results
Model Number ONXANE-25
Device Problem Measurement System Incompatibility (2982)
Patient Problem No Code Available (3191)
Event Date 05/23/2018
Event Type  Injury  
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.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, the surgeon sized with the yellow on-x valve sizer and the 25 sizer seemed like a good fit.He tried to implant a 25 mm on-x valve but really struggled getting the valve into the annulus.The patient's aorta tore and needed repair.The 25 valve was implanted however the surgeon does not think that the sizer was a representation of the valve that was packaged in the 25 mm box.The valve seemed larger than the sizer.
 
Event Description
According to initial reports, the surgeon sized with the yellow on-x valve sizer and the 25 sizer seemed like a good fit.He tried to implant a 25 mm on-x valve but really struggled getting the valve into the annulus.The patient's aorta tore and needed repair.The 25 valve was implanted however the surgeon does not think that the sizer was a representation of the valve that was packaged in the 25 mm box.The valve seemed larger than the sizer.
 
Manufacturer Narrative
The manufacturing records for the onxane-25 serial number sn(b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.The onxane-25 sn (b)(4) was implanted (b)(6)2018 in the aortic position of a 54 year old male.The surgeon sized for a 25mm valve, but had trouble making the valve fit, tearing and patching the aorta in the process.The surgeon feels the sizer misrepresents the valve, in particular that the valve is larger than the sizer.The "yellow" sizer is from instrument set model onxl3.Contrary to the surgeon's feeling, the sizer for onxl3 is actually larger than the valve by a small amount to help prevent oversizing.We don't have any more details of the operation, but the most likely scenario is that the surgeon sized the native annulus, then placed the sutures, and then tried to lower the valve into place without first re-checking the fit with the sizer.The suture line (depending upon type and technique) can have a cinching effect on an annulus, effectively reducing the annulus diameter.Forcing the valve in to the point of aortic rupture strongly hints at oversizing.The instructions for use caution against oversizing and recommends a "comfortable fit" [ifu].This is a case of inappropriate valve sizing, most likely related to surgical technique and not related to valve (or sizer) performance.Surgeon training/retraining on sizing technique may be appropriate.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.
 
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Brand Name
ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER
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 Key7638177
MDR Text Key112338513
Report Number1649833-2018-00124
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,user f
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberONXANE-25
Was Device Available for Evaluation? No
Distributor Facility Aware Date05/29/2018
Date Manufacturer Received05/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age53 YR
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