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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Insufficiency, Valvular (1926); Thrombus (2101)

Event Date 10/08/2019

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, onxmc 25/33 was implanted in the mitral position on (b)(6) 2014.Then on (b)(6) 2019 this valve was explanted and replaced with a new onxmc 25/33 into the mitral position.

Manufacturer Narrative

According to the initial report, onxmc-25/33 was implanted in the mitral position on (b)(6) 2014.Then on (b)(6) 2019 this valve was explanted and replaced with a new onxmc 25/33 into the mitral position.The manufacturing records 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 clinical/medical review was performed.Onxmc-25/33 was implanted in the mitral position of a 46-year-old female patient on (b)(6) 2014.This valve was explanted and replaced by another onxmc-25/33 on (b)(6) 2019 (5 years and 246 days post-implant).The operative report for (b)(6) 2019 and discharge summary of (b)(6) 2019 were made available.The explanted valve was not returned to the manufacturer for examination.The medical history indicated the patient had endocarditis (infection) in 2016 with vegetations on the valve as observed by transesophageal echocardiogram (tee).However, the valve did not appear to demonstrate any dysfunction.This was treated with antibiotics.A subsequent fluoroscopy (date is not given) suggested suboptimal valve function and a follow-up transthoracic echocardiogram (tte) revealed findings consistent with valve thrombosis.Inr reported as 2.85, but historical compliance is unknown.Upon surgery to replace the valve, the surgeon observed mature thrombosis on the valve as well as apparent interference with the valve leaflets by residual ¿subvalvular apparatus/prior valve leaflet.¿ the latter was removed and the new valve was oriented in an anti-anatomical position with resulting ¿excellent leaflet opening and closing.¿ the patient was discharged to home nine days later.This is a case of a thrombosed mitral on-x valve.The genesis for the thrombus may be related to endocarditis.However, the function of the valve was, apparently, also compromised to some extent by anatomic interference with the patient¿s native mitral valve leaflets which had been retained at the original implantation.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.Similarly, endocarditis occurs at a rate of 1.2% per patient-year [iso 5840:2005e].Both events are listed as potential complications in the valve instructions for use (ifu) as is prosthesis nonstructural dysfunction (in this case, anatomic interference).Reoperation and explantation are recognized possibilities as a result of such complications [ifu].The root cause is valve thrombosis of possible infection origin and potential valve dysfunction exacerbated by anatomic interference.The on-x valves undergo a validated terminal sterilization process; therefore, the potential infection is likely not related to the on-x product.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: 9272921
• MDR Text Key: 180607011
• Report Number: 1649833-2019-00069
• 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
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 51 YR