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

Model Number ONXM-25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Insufficiency, Valvular (1926); No Information (3190)

Event Date 10/23/2018

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, onxm-25 sn (b)(4), implanted: (b)(6) 2015, was explanted (b)(6) 2018 and replaced with onxm-27/29 sn (b)(4).

Event Description

According to initial reports, onxm-25 sn (b)(4) implanted (b)(6)2015 was explanted (b)(6)2018 and replaced with onxm-27/29 sn (b)(4).Additional information received.Patient has recurrent mitral valve dehiscence, pvl.First prosthetic valve replacement surgery was in 2014 with a st.Jude valve.Patient has been discharged.No other information would be released.

Manufacturer Narrative

The manufacturing records for the onxm-25 sn (b)(4) 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.A review of the available information was performed.The onxm-25 sn (b)(4) was implanted (b)(6)2015 in the mitral position of a 33-year-old female.This was explanted and replaced with onxm-27/29 sn (b)(4) on (b)(6)2018 (3 years 133 days post-implant).The original valve was itself implanted subsequent to a previous valve replacement in 2014 with a st.Jude valve.The only diagnostic information that has been provided is "recurrent mitral valve dehiscence, pvl" (paravalvular leak), that is, the valve became separated from the tissue to which it was sewn causing the blood to flow around the valve rather than through it.The two most likely causes of pvl are surgical suturing technique and tissue degeneration.Because of the recurrent nature, the latter is the more probable cause and that suggests infection (endocarditis).But without further evidence we do not have sufficient justification to make endocarditis the definitive reason for the pvl's.Likewise, we do not have enough information to conclude what, if any, contribution the on-x valve has to the pvl 's nor what role it may have had in the decision to explant.The instructions for use for the on-x valve lists prosthesis perivalvular leak (as well as endocarditis) as a possible complication of mechanical heart valve replacement and includes the possibility of reoperation and/or explantation [ifu].Historically, major pvl occurs at a rate of 0.6%/patient-year for rigid heart valves [iso 5840:2005].Paravalvular leak is the primary contributor leading to the need for reoperation, explantation, and replacement of the previous mitral prosthetic heart valve.Because the source of the pvl is not identified, there is no evidence to indicate that the on-x valve had any relationship to the complications necessitating its removal and replacement.Root cause for this event is 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.

Event Description

According to initial reports, onxm-25 sn(b)(4).Implanted (b)(6) 2015 was explanted (b)(6) 2018 and replaced with onxm-27/29 sn (b)(4).Additional information received.Patient has recurrent mitral valve dehiscence, pvl.First prosthetic valve replacement surgery was in 2014 with a st.Jude valve.Patient has been discharged.No other information would be released.

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.

• Brand Name: ON-X PROSTHETIC MITRAL VALVE WITH STANDARD 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: 8143867
• MDR Text Key: 129791530
• Report Number: 1649833-2018-00173
• 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,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXM-25
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/19/2018
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 36 YR