MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER; HEART-VALVE, MECHANICAL

Model Number ONXACE-25

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

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, "the patient was presented with lower limbs embolic events and found to have the source of it from his thrombosed aortic valve.He looks compliant and never had inr below 1.5".

Manufacturer Narrative

The manufacturing records for the onxace-25 (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.An evaluation of the returned valve was performed.Prior to decontamination, visual examination of valve shows leaflet and housing intact.Some tissue growth was observed on valve assembly.After decontamination, surface fractures were observed near the pivot location.There are no visual anomalies on the leaflets or rest of the housing.Valve was sent for sem analysis.Elements of surgical steel that would indicate a surgical tool caused the surface fractures were observed.Due to the location of the fractures, the valve could not be disassembled without complete fracture of the housing.Functional and dimensional evaluation could not be done.The manufacturing review indicates no issues with original build.Observed surface fractures most likely caused by contact with a metallic tool iatrogenic.A review of the available information was performed.The onxace-25 sn (b)(4).Was implanted in the aortic position of a male patient.No record of this implant appears in the device tracking database (the valve was implanted in the uk).Consequently, the date of surgery is unknown but reported as "2.5 years ago." the only clinical information we have is a surgeon's comment "the patient was presented with lower limb embolic events and found to have the source of it from his thrombose d aortic valve.He looks compliant and never had inr below 1.5." the valve was explanted and photos show prominent thrombotic material on both inflow and outflow sides of the valve.The inflow side thrombus covered one leaflet almost in its entirety, but the other was mostly exposed.The outflow side thrombus was preferential to the pivot regions of the valve.The valve was returned to the manufacturer for examination, but arrived without the thrombus material.Engineering analysis only identified anomalies typically associated with extraction by metal surgical tools.Due to the condition of the returned valve, functional and dimensional evaluation could not be done.Manufacturing records show normal construction.While the warfarin anticoagulation history appears to be according to the recommendations of the manufacturer [ifu), no mention is made about the use of aspirin, which is also in the recommendations of the manufacturer (ifu] and acc/aha guidelines [nishimura 2017, p.27).Not all countries abide by the acc/aha guidelines, so we do not know whether or not aspirin was prescribed as a part of the anticoagulation strategy.With the limited clinical information we have, this is a thrombosed on-x aortic valve whose origin appears to be in the interior of the valve, particularly in the pivot region where high velocity flows can foster platelet activation.The anticoagulation therapy is reported to be within the recommended range for warfarin administration, but the use or lack of aspirin-an antiplatelet agent-is not documented.Thrombosis is a rare, but known potential complication of prosthetic valve replacement occurring at a historical rate of 0.8% per patient-year for rigid heart valves.Thromboembolism is also a known potential complication occurring at a historical rate of 3.0%/patient-year [iso 5840:2005e].Both are recognized as a potential adverse event for the on-x valve along with the potential for reoperation and explantation this is a case of aortic valve thrombosis.Thromboembolic symptoms of the lower limbs were attributed to this thrombosis.While warfarin administration nominally appears to be within the guidelines, compliance with the recommendation of aspirin is not documented.Therefore, while this is a valve-related adverse event, compliance with the anticoagulation recommendations is not firmly established and the relationship to expected valve performance may be affected accordingly.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.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, "the patient was presented with lower limbs embolic events and found to have the source of it from his thrombosed aortic valve.He looks compliant and never had inr below 1.5.".

• Brand Name: ON-X PROSTHETIC AORTIC VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1655 roberts blvd; kennesaw GA 30144
• MDR Report Key: 8387769
• MDR Text Key: 137739789
• Report Number: 1649833-2019-00012
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/14/2022
• Device Model Number: ONXACE-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Distributor Facility Aware Date: 03/04/2019
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention