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

Model Number ONXM-31/33

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Regurgitation (1716); Regurgitation (2259)

Event Date 01/24/2018

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 the initial report and implant summary card received, size 31/33 onxm (mitral heart valve with standard sewing ring), serial number (b)(4) was implanted on (b)(6) 2015 and explanted on (b)(6) 2018 due to undisclosed reasons.Additional information was received via operative notes.According to the operative notes, ¿this is a (b)(6)-year-old gentleman who several years ago underwent aortic and mitral valve mechanical valve replacement subsequently was noticed to have severe aortic and mitral regurgitation due to perivalvular leaks.He was a heavy weightlifter that might have contributed to his perivalvular leak development.¿ this investigation is relegated to the onx mitral valve.

Event Description

According to the report, size 31/33 onxm (mitral heart valve with standard sewing ring), serial number 4219316 was implanted on 05/19/2015 and explanted on 01/24/2018 due to undisclosed reasons.

Manufacturer Narrative

The manufacturing records for the onxm-31/33 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.46.69 year old male implanted with onxm-31/33 (sn (b)(4)) and onxace-21 (sn (b)(4)) via double valve procedure on 05/19/2015 and required explant on /(b)(6)2018 indicated for severe aortic regurgitation due to perivalvular leak [pvl) of the aortic valve and severe mitral regurgitation due to perivalvular leak of the mitral valve.The surgeon mentions in the operative notes that the patient was a heavy weightlifter which "might have contributed to his perivalvular leak development." pvl was noted in several spots around both valves intraoperatively.No information is available regarding indication for initial double valve procedure or other patient comorbidities.Regardless, the prior surgical history and combination of strenuous strength training (as suggested by the surgeon), would be a plausible cause for development of pvl and subsequent regurgitation.There is no indication that the reported events are attributed to the on-x valve.Pvl is a rare but recognized risk of prosthetic valve replacement, as is the possibility of explantation].In a multicenter study with 142 on-x aortic valves followed for a mean of 4.5 years, only one case of late pvl was observed and it was repaired on re-operation [mcnicholas 2006).Another study of 184 aortic on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007].In a 10-year experience at a single center, 428 on-x implants (264 aortic and 164 mitral) resulted in two cases of paravalvular leak, both considered minor and requiring no intervention [tossios 2007].In a european multicenter study, out of 691 on-x patients followed for a median of 5.5 years and up to 12.6 years, there were 4 observed late incidents of pvl in the aortic position [chambers 2013).Objective performance criterion report a rate of all pvl of 1.2 %/patient-year major pvl of 0.6%/patient-year.The instructions for use (ifu) acknowledge the potential for perivalvular leak and explantation due to complications.The valve was performing as expected.This event does not identify additional hazards or modify the probability and severity of existing hazards.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 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln.; austin TX 78752
• MDR Report Key: 7467947
• MDR Text Key: 106710387
• Report Number: 1649833-2018-00021
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Model Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2018
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 46 YR