MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART-VALVE, MECHANICAL

Model Number ONXACE-21

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

Patient Problems Abscess (1690); Aortic Regurgitation (1716); Congestive Heart Failure (1783); Endocarditis (1834); Pseudoaneurysm (2605)

Event Date 05/01/2018

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 operative notes, "an echocardiogram revealed a large dehiscence of prosthetic mechanical aortic valve secondary to endocarditis and a large pseudoaneurysm of the ascending aorta.".

Event Description

According to operative notes, "an echocardiogram revealed a large dehiscence of prosthetic mechanical aortic valve secondary to endocarditis and a large pseudoaneurysm of the ascending aorta.".

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxace-21 sn [serial number] (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-21 sn (b)(4) implanted 2014 nov 26 in aortic position, explanted and replaced (b)(6)2018 (3 years 156 days post-implant) by onxace-21 sn (b)(4).The patient is a male of unknown age, but severe pericarditis was noted at the original implant surgery.The reoperative report of 2018 noted that he has hiv and renal insufficiency.Preoperative transesophageal echo (tee) revealed severe paravalvular leak (pvl) as a result of valve dehiscence secondary to endocarditis with large pseudoaneurysm of the ascending aorta.Endocarditis is the precipitating event leading to deterioration of the annular tissue and consequent loss of attachment by the sutures connecting the valve to it.With the detachment, some of the blood was able to flow around the valve during diastole (regurgitation) rather than being obstructed by a closed valve.There is no indication that the valve itself failed to function as designed.Endocarditis, paravalvular leak, and reoperation are all known potential adverse events associated with prosthetic valve replacement [instructions for use].For rigid heart valves, endocarditis occurs at a historic rate of 1.2%/patient-year, all pvl occurs at a rate of 1.2%/patient-year, and severe pvl at a rate of 0.6%/patient-year [iso 5840:2005].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 an 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].Loss of attachment to deteriorated annular wall as a consequence of infection (endocarditis) resulted in severe aortic insufficiency via paravalvular leakage.There is no indication that the initial on-x valve itself failed to function and performed as designed.No further action is required at this time.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 21
• 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: 7613010
• MDR Text Key: 111439908
• Report Number: 1649833-2018-00118
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/25/2018
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other