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

Model Number ONXACE-23

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

Patient Problems Insufficiency, Valvular (1926); No Code Available (3191)

Event Date 03/09/2018

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, a (b)(6) year old female had onxace-23 sn (b)(4) implanted on (b)(6) with a possible explant on (b)(6) 2018.According to operative notes, explant due to prosthetic aortic paravalvular leak, status post 2 previous aortic valve replacements.

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxace-23 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.During the investigation no non-conformances or deviations were noted.Onxace-23 sn (b)(4) implanted (b)(6) 2011 in 49 year old female.Operative notes from 03/09/2018 indicate that this valve was replaced in 2013 by a bioprosthesis due to severe paravalvular leak (pvl), which is, in turn, now also replaced due to pvl in the same location by an on-x valve.This latest reoperation included mitral valve replacement (mvr) with a [mechanical valve] (due to moderate to severe mitral insufficiency) and tricuspid annuloplasty.The patient now has a second on-x valve in the aortic position, a mechanical valve in the mitral position, and a tricuspid valve annuloplasty ring.The operative notes go on to say ¿other medical issues included cva with residual left-sided weakness, hypertension, hyperlipidemia, copd/asthma, paroxysmal atrial fibrillation, and solitary kidney with chronic kidney disease.¿ so not only has this patient experienced pvl, twice, but also a stroke and arrhythmia.But none of these ¿other medical issues¿ are further explained and so we have no way of associating this information with any of the previous valves.This report, then, will focus on the pvl¿s, which are documented.Pvl and subsequent reoperation are both recognized risk factors associated with mechanical valve replacement.We do not know the cause of the pvl¿s in this case, only that they were severe both times and seemed to occur in the same location.In any case, industry-wide historical records indicate a major pvl rate for rigid valve replacement of 0.6% per patient-year [iso 5840:2005].Severe paravalvular leak of unidentified origin resulted in replacement of the on-x aortic valve, and again of a subsequent bioprosthesis.Because we do not know the origin of the pvl, we do not know what, if any, relationship it has to the original on-x valve nor its bioprosthetic successor.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 the initial report, a 49 year old female had onxace-23 sn (b)(4) implanted on (b)(6) 2011 with a possible explant on 03/09/2018.According to operative notes, explant due to prosthetic aortic paravalvular leak, status post 2 previous aortic valve replacements.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; bldg. b; austin TX 78752
• MDR Report Key: 7588590
• MDR Text Key: 110703557
• Report Number: 1649833-2018-00110
• 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: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2016
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2018
• Date Manufacturer Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR