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

Model Number ONXA UNK

Device Problem Insufficient Information (3190)

Patient Problem Embolism (1829)

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 journal article, "the need for transparency of clinical evidence for medical devices in (b)(6)," patient had an embolic stroke 5 months after implant of on-x valve.

Manufacturer Narrative

A review of the available information was performed.Journal article references the case of a 51-year-old female who had an embolic stroke at five months post-implant with an aortic on-x mechanical valve, a few days after her inr was recorded to be 1.9.This is after ce mark approval for inr 1.5 ¿ 2.0, which was presumed to be based upon the interim results of the proact study [puskas 2014].The point of the article is not this specific event, but rather an example of the authors¿ perceived lack of transparency in medical device approvals in the european union.Consequently, this is all the information we have on this event and attempts to contact the lead author for details concerning it have not been returned.Without additional details, we can only state that the patient¿s stroke may have been valve related, but that is not conclusive as we do not know the inr history preceding the event (other than the single inr reading).We also do not know if the proposed thromboembolism (te) originated with the valve.With the lack of background information, we can only place this in the context of the historical record.Thromboembolism is a known potential complication occurring at a historical rate of 3.0 %/patient-year [iso 5840:2005(e)].It is recognized as a potential adverse event for the on-x valve [ifu].The puskas article referenced above for the proact study interim results indicated an all te rate (neurological and peripheral) of 2.67 %/patient-year for the treatment group (inr 1.5 ¿ 2.0) and 1.59 %/patient-year for the control group (inr 2.0 ¿ 3.0).The difference was not statistically different (p=0.164) and both were below the iso objective performance criteria.It is probable that a thromboembolism induced the neurologic stroke.Although valve-relatedness is implied, the information available from this article is insufficient to determine with certainty what, if any, relationship the stroke had to do with the valve.No further action recommended.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 PROSTHETIC AORTIC VALVE UNKNOWN CONFIGURATION
• 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: 9250815
• MDR Text Key: 164875247
• Report Number: 1649833-2019-00064
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXA UNK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/05/2019
• Initial Date Manufacturer Received: 10/05/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/05/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR