MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X AORTIC VALVE UNKNOWN; HEART VALVE MECHANICAL

Model Number ONXA UNK

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Embolism (1829); Occlusion (1984); Thrombus (2101)

Event Date 09/12/2017

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, "patient who had an on-x aortic valve implanted in (b)(6) 2016 presented to vascular dept with acute occlusion of popliteal artery as a result of thrombus emboli.Mr.(b)(6) did not have any more in depth information on patients condition at time of conversation but said he could get same is required and is happy to be contacted by field assurance.Treatment for thrombotic emboli of popliteal artery." the following information was requested 10/20/2017 from the surgeon: " what is the current status of the patient; what is the date of event; what is the product code for the aortic valve; what steps were taken to address the event; is the serial number for the valve available; what was the implant date; and are operative notes available." the surgeon's response 10/23/2017 as follows: "the patient is well as far as i am aware.The event occurred on (b)(6) 2017 and required vascular surgery.Inr was within the required therapeutic range (1.7) but has now been increased.The valve was implanted on(b)(6) 2016.

Manufacturer Narrative

A review of manufacturing records was not performed as serial number is unknown.A review of the available information for the on-x valve reported as implanted (b)(6) 2016 was performed.  a diagnosis of acute thromboembolic occlusion of popliteal artery (b)(6) 2017 (314 days post-implant) requiring vascular surgery was reported.The international normalized ratio (lnr) was 1.7, since increased.The patient was last reported to be doing well.No other information is available.With the information provided, this is a probable thromboembolic event in a peripheral artery.Inr was appropriate for single on-x aortic valve recipient, barring other medical conditions or diet that may influence anticoagulation level.It would be considered a noncerebral embolic event according to the criteria of akins, et al.[akins 2008).Thromboembolism (te) is a recognized potential adverse event for mechanical heart valve recipients [instructions for use].In a study comparing events for single on-x aortic valve recipients with one group maintained at an inr of 1.5 - 2.0 (treatment) and another at an inr of 2.0 - 3.0 (control) there were 4 peripheral te's recorded for the treatment group and 1 for the control group at a rate of 0.59 and 0.13 %/patient-year, respectively.There was no statistical difference between those on standard inr versus those on the lower inr, but both groups experienced them [puskas 2014].The ifu lists prosthesis thrombosis as a known potential risk associated with the use of the on-x valve.Thromboembolic events are not an unexpected adverse event for mechanical heart valves.The on-x 614 heart valve design fmea has described the event outcome addressed in section 5, item 5, *5r.Category ¿ biological, failure mode ¿ thrombosis, failure analysis/failure mode effect ¿ potential for thrombus & thromboembolisms, cause of failure ¿ reduced inr, anticoagulation regimen.Thrombosis is a monitored event and is assessed in the biannual risk assessment for the on-x heart valve.Root cause for this event is acute thromboembolic occlusion of peripheral (popliteal) artery.No further action is warranted at this time.

Event Description

According to initial reports, "patient who had an on-x aortic valve implanted in (b)(6) 2016 presented to vascular dept with acute occlusion of popliteal artery as a result of thrombus emboli.Mr.Jones did not have any more in depth information on patients condition at time of conversation but said he could get same is required and is happy to be contacted by field assurance.Treatment for thrombotic emboli of popliteal artery." the following information was requested 10/20/2017 from the surgeon: " what is the current status of the patient; what is the date of event; what is the product code for the aortic valve; what steps were taken to address the event; is the serial number for the valve available; what was the implant date; and are operative notes available." the surgeon's response (b)(6) 2017 as follows: "the patient is well as far as i am aware.The event occurred on 12 september 2017 and required vascular surgery.Inr was within the required therapeutic range (1.7) but has now been increased.The valve was implanted on (b)(6) 2016.".

• Brand Name: ON-X AORTIC VALVE UNKNOWN
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 6976932
• MDR Text Key: 90232093
• Report Number: 1649833-2017-00080
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXA UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/27/2017
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention