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

Model Number ONXANE-25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 10/24/2018

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 the initial report, patient received an on-x aortic valve in (b)(6) 2016 and had a stroke at inr 1.8 on (b)(6) 2018.

Manufacturer Narrative

The manufacturing records for the packaging of valve onxane-25 serial number (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 a non-conformance was noted; however, it is unrelated to the reported event.A review of the available information was performed.Onxane-25 sn (b)(4) implanted (b)(6) 2016.The patient (unknown age or gender) experienced a stroke assumed to have occurred approximately (b)(6) 2018 (1 year 309 days post-implant).The patient's inr is reported to have been 1.8 at the time, though it is not clear from the text if this was actual or target ".On-x patient had a stroke while the patient was at an 1.8 inr." we also do not have an inr history to evaluate long-term compliance.An inr of 1.8 for the isolated on-x aortic valve is the current recommendation [ifu, puskas 2014 , puskas 2018], but with no record of inr compliance, nor any medical records, we can only evaluate this event from the perspective of historical experience.Stroke is a recognized potential adverse event [ifu] and for rigid heart valve replacement, the rate of occurrence is 3.0 %/valve-year [iso 5840:2005].Stroke is a recognized potential adverse event for any mechanical aortic heart valve recipient, but limited information prevents us from concluding what, if any, relationship the valve has to its occurrence in this particular case.Root cause for this event is unknown.No further action is required at this time.Should additional information become available, it will be evaluated and the complaint will be reopened.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 the initial report, patient received an on-x aortic valve in (b)(6) 2016 and had a stroke at inr 1.8 on (b)(6) 2018.

• 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 Key: 8084668
• MDR Text Key: 127612040
• Report Number: 1649833-2018-00167
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXANE-25
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/25/2018
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other