MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X PROSTHETIC MITRAL VALVE WITH CONFORM-X SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombus (2101)

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 initial reports, patient admitted to hospital with a thrombosed on-x mitral valve.The patient had stopped taking warfarin.The valve was explanted and replaced with a tissue valve.Patient is doing well.

Event Description

According to initial reports, patient admitted to hospital with a thrombosed on-x mitral valve.The patient had stopped taking warfarin.The valve was explanted and replaced with a tissue valve.Patient is doing well.

Manufacturer Narrative

The manufacturing records for the onxmc-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.Document change orders le 14228, le 14669, were issued for leaflet tuning as a part of the standard manufacturing process.A review of the available information was performed.According to the report, "we had a young lady who stopped taking warfarin, who came in with a thrombosed onyx mitral valve.The serial number of the valve was (b)(6).It was a 25/33 valve.We proceeded to take it out and put a tissue valve and she is doing fine." we do not have any objective medical records to corroborate the assessment.We do not have a date of surgery, so we do not know the elapsed time until the thrombosis was diagnosed.The information provided suggests an aortic on-x valve thrombosed following inadequate anticoagulation therapy.Thrombosis is a rare but known potential complication of prosthetic valve replacement [ifu] occurring at a historical rate of 0.8% per patient-year for rigid heart valves.The ifu states the recommended anticoagulation therapy and acknowledges the possibility of complications such as thrombosis with the potential for reoperation and explantation.This is a case of valve thrombosis, but we do not know the origin nor age of the clot.The information provided points to inadequate anticoagulation as the likely cause.However, a definitive root cause remains unknown.No further action is required without additional information.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 MITRAL VALVE WITH CONFORM-X SEWING RING
• 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: 8497298
• MDR Text Key: 141386153
• Report Number: 1649833-2019-00023
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/07/2023
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/01/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention