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

Model Number ONXAN UNK

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Weakness (2145)

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 admitted to hospital with acute embolic stroke, inr 1.8.No source of the embolus found.Inr being run at 2.5-3.5.Significant speech loss and right-sided weakness.

Manufacturer Narrative

The manufacturing records for the onxaap-25, 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.A review of the available information was performed.A 48-year-old male patient implanted with a "25 mm mechanical on-x valsalva root replacement" (onxaap-25, sn (b)(4)) on (b)(6) 2018 indicated for symptomatic recalcitrant bicuspid aortic valve with sinotubular junction aneurysm.Medical notes state "he is consistently kept a therapeutic inr ranging from 1.8-2.4 as per valve specific guidelines managed at 3 rivers ihs clinic.He was recently admitted to hospital with an acute embolic stroke in the setting of an inr of 1.8.There was no source of embolus found.He did undergo a surface echo but no tee because they did not want to sedate him given his acute stroke and they felt like this would not change the recommendation which was to run his inr higher at 2.5-3.5.He did undergo mechanical thrombectomy because he was not a tpa candidate.He has continued to progress but still has pretty significant speech and right-sided weakness." the instructions for use for the on-x model ascending aortic prosthesis (onxaap) state that the "selection of an anticoagulant or anticoagulant/antiplatelet regimen is based on the particular needs of the patient, the clinical situation and established professional guidelines." however, the onxaap did not receive an explicit inr 1.5-2.0 approval from the fda.The inr in this case was managed between 1.8-2.4 per clinic guidelines and the embolic stroke occurred at 1.8.Inr was then elevated to 2.5-3.5.No source of embolus was found.Thromboembolism is a known potential complication of prosthetic valve replacement [ifu-aap] occurring at a historical rate of 3.0% per patient-year for rigid heart valves [iso 5840:2005e].Root cause for the thrombus is unknown based on the available information.Thromboembolism is a recognized potential adverse event for any mechanical aortic heart valve recipient.No further action is required.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.

• Brand Name: ON-X AORTIC ANATOMIC 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 Key: 9296730
• MDR Text Key: 167587093
• Report Number: 1649833-2019-00071
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXAN UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/25/2019
• Date Manufacturer Received: 10/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 48 YR