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-23

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 01/09/2020

Event Type  Death  

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 the report, the surgeon asked the circulating nurse for a 23 mm on-x mitral valve, but he was unknowingly given a 23 mm on-x aortic valve and implanted it.The patient could not be weaned off of bypass and expired in surgery.The implant error was discovered the next day.Per communication with the hospital this was not a product failure, but a misidentification by the surgery staff.

Manufacturer Narrative

The manufacturing records for onxace-23, sn (b)(6) 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 onxace-23, sn (b)(6) was implanted on (b)(6) 2020 in the mitral position of a 56-year old female.The operative report was made available and indicated that all attempts to wean the patient off of cardiopulmonary bypass were unsuccessful.The surgical team was unaware of the error and the patient died on the operating table.A transesophageal echocardiogram (tee) after implantation indicated ¿¿the valve to be functioning well with full motion of the leaflets.¿ of note, the manufacturer does not distribute a size 23mm mitral on-x valve in the united states, where this took place.There was no dysfunction of the valve.Its improper placement resulting in non-physiologic directional blood flow is the root cause of the unfortunate outcome.This would be classified as an operative mortality.For mitral valve replacement (mvr), a 2001 review shows a 6.04% operative mortality [edwards 2001].The instructions for use (ifu) for the on-x valve acknowledge death as a potential outcome following prosthetic heart valve replacement.A risk analysis was performed.The dfmea includes a review of the risk associated with mis-identifying the valve type.This risk is mitigated as far as possible by labeling the valve brand, valve size, valve serial number, and sterility expiration on the packaging.This event does not identify additional hazards or modify the probability and severity of existing hazards.No further actions are necessary based on the rate of occurrence.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 WITH CONFORM-X SEWING RING AND 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: 9681390
• MDR Text Key: 178158849
• Report Number: 1649833-2020-00088
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR