MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 23; HEART-VALVE, MECHANICAL

Model Number ONXACE-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Insufficiency (1715); Congestive Heart Failure (1783)

Event Date 01/11/2018

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 registration cards received, size 23 onxace (aortic heart valve with conform-x sewing ring and extended holder) sn (b)(4), was implanted on (b)(6) 2012 and explanted and replaced with size 23 onxane (aortic heart valve with anatomic sewing ring and extended holder) sn (b)(4) on (b)(6) 2018 for undisclosed reasons.Note: this investigation is relegated to onxace 23 (sn (b)(4)).Additional information was received via operative notes.The operative notes indicate that the patient became progressively dyspneic and fatigued.The patient also experienced new onset of lower extremity edema.These symptoms were consistent with acute on chronic diastolic and valvular congestive heart failure.The echocardiogram revealed severe perivalvular insufficiency.

Event Description

According to the initial report and implant registration cards received, size 23 onxace (aortic heart valve with conform-x sewing ring and extended holder) sn (b)(4)., was implanted on (b)(6) 2012 and explanted and replaced with size 23 onxane (aortic heart valve with anatomic sewing ring and extended holder) sn (b)(4).On (b)(6) 2018 for undisclosed reasons.Note: this investigation is relegated to onxace 23 (sn (b)(4).Additional information was received via operative notes.The operative notes indicate that the patient became progressively dyspneic and fatigued.The patient also experienced new onset of lower extremity edema.These symptoms were consistent with acute on chronic diastolic and valvular congestive heart failure.The echocardiogram revealed severe perivalvular insufficiency.

Manufacturer Narrative

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.A review of the available information was performed.55.27 year-old female patient received onxace-23 (sn (b)(4).On (b)(6) 2012 indicated for symptomatic critical aortic stenosis with syncope and required explant and replacement via onxane-23 on (b)(6) 2018 indicated for severe prosthetic perivalvular insufficiency and acute class iii valvular and diastolic congestive heart failure (chf).Patient history is significant for osteoporosis, hypertension, lower extremity venous disease, sleep apnea, smoking, and obesity (bmi33).Operative notes were received.After receipt of the onxace-23 in 2012, patient was enrolled into the low risk aortic arm of the proact (prospective randomized on-x anticoagulation clinical trial) study receiving plavix anticoagulation.It was noted that "later postoperative course was complicated by what appeared to be an embolic cva [cerebrovascular accident]" and was switched back over to coumadin for anticoagulation.Surgeon notes that patient "has been doing well until recently," sometime in 2017 or early 2018.Patient presented with progressive dsypnea and fatigue with new onset lower extremity edema consistent with symptoms of chf related to severe perivalvular insufficiency.Preoperatively, it was noted that no evidence of infection was present.No operative findings indicate an etiology for the insufficiency.However, it was noted that "in the distant past there was a mild leak and now it is severe.There is no indication noted within the operative notes that the valve failed and it is not inconceivable that the reported events are associated with comorbid conditions such as hypertension, lower extremity venous disease, smoking, and obesity.Thrombosis and thromboembolism are all recognized risk factors for mechanical mitral valve replacement cases.Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves while the guidelines state that even with adequate anticoagulation the risk of thromboembolism is 1% - 2% per year [nishimura].Pvl [paravalvular leak] is a rare but recognized risk of prosthetic aortic 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 criteria report a rate of all pvl of 1.2 %/patient-year, major pvl of 0.6%/patient-year.A definitive root cause for the reported events is unknown based on the available information.It is likely that the reported events are associated with comorbid conditions such as hypertension, lower extremity venous disease, smoking, and obesity.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: ONX AORTIC CONFORM EXT 23
• 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: 7422975
• MDR Text Key: 105240173
• Report Number: 1649833-2018-00019
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/20/2018
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 60 YR