MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, surgeon implanted onxmc-25/33 sn (b)(4) and realized that one of the leaflets was not moving.He explanted the valve and re-sutured and implanted the same onxmx 25/33 valve a second time.One of the leaflets was still not moving.He explanted and changed to a different mechanical valve.One of the leaflets was not moving with the second valve.Patient passed away during the procedure.

Manufacturer Narrative

A sample evaluation was performed for the returned product.The following methods of observation were utilized for the evaluation; visual, microscopy, engineering processing record, sem microscopy report.Prior to decontamination, visual examination of valve showed no obvious signs of damage.Both leaflets were freely moving.After decontamination, inspection of the part under the microscope showed damage to the leaflets.There were scratches and a chip on the left leaflet.The part was tested using a size 25-33 rotator.The rotator was easily able to rotate the part both clockwise and counterclockwise with no resistance.The part was disassembled, cleaned, and reinspected per our standard process and specifications.The scratches and chip were also evident during the reinspection.The part was sent to an outside lab for sem microscopy.Evidence of contact with a metallic instrument was found on the leaflet during this inspection in the chipped region of the leaflet.The manufacturing records for the onxm-25/33 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.A review of the available information was performed.Onxmc-25/33 sn (b)(6) (incorrectly identified as (b)(6) in a preliminary field report) was implanted in the mitral position of a 42-year-old female patient.Date of surgery is unknown.The surgeon observed that one of the leaflets was not moving, explanted the valve, re-sutured the same valve, made the same observation, again explanted the valve, and tried a st.Jude regent mechanical valve which yielded the same result.The patient did not survive the surgery, though the timing of the death is not given.The on-x valve was returned to the manufacturer.A review of the manufacturing records indicate a normally processed valve meeting all construction criteria.Both leaflets were observed to be freely moving and the valve rotated within its cuff without undue resistance.Scratches and a small chipped area were observed on one of the leaflet edges.Evidence of metallic tool usage was noted by scanning electron microscopy.While of potential long-term concern were the chip created at implantation, it was more likely generated at explantation, i.E.Metal tools used to remove the valve from the patient.In any case, neither the scratches nor chip were sufficiently large to have contributed to leaflet movement impairment, which was the reason for the explantation.There are multiple reasons why a leaflet may not be moving as expected, but the fact that a replacement valve from a different manufacturer exhibited the same deficiency suggests that the valve is not the probable cause.It is more likely an external influence such as suturing technique, anatomic interference, or some other unidentified source.Therefore, the appropriate classification would be prosthetic valve dysfunction, most likely nonstructural.With the limited information we have, there is not enough to ascertain the primary reason for the dysfunction, nor is there enough information to determine what, if any, relationship the valve has to the observation.The instructions for use [ifu] list both structural and nonstructural valve dysfunction as well as prosthesis leaflet entrapment as potential complications of prosthetic valve implantation with the possibility of explantation, reoperation, and/or death.Root cause for this event valve dysfunction, most likely due to external, unidentified, factors.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: ONX MITRAL CONFORM 25/33
• 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: 9296591
• MDR Text Key: 165609806
• Report Number: 1649833-2019-00070
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/18/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 42 YR