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

Model Number ONXACE-21

Device Problem Perivalvular Leak (1457)

Patient Problem Bacterial Infection (1735)

Event Date 06/01/2017

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 implant registration cards, onxace-21 sn (b)(4) implanted (b)(6) 2011.Onxace-21 sn (b)(4) implanted (b)(6) 2017 same patient, same position.No alleged deficiency made to sn (b)(4).This complaint is relegated to sn (b)(4).Additional information from the surgeon is as follows, " this valve was replaced for paravalvular leak unlikely related to implant and more likely due to bacteraemia post-op.Valve explanted was in good nick [condition].Can't send you the operation report.Patient came through repeat surgery well.".

Manufacturer Narrative

The manufacturing records for the onxace-21 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 was performed of the available information.Initially reported, onxace-21 sn (b)(4) implanted (b)(6) 2011 in the aortic position of a (b)(6) male patient, explanted and replaced by onxace-21 sn (b)(4) on (b)(6) 2017 (5 years 178 days post-implant, patient now (b)(6)).This information was noted from the implant registration cards since the patient and position were the same for both.Follow up questioning received the response that the explanted valve was actually in "good nick", i.E.Good shape, and that the explantation was for paravalvular leak (pvl), most likely due to bacteraemia.This suggests it was the native annular tissue which lost its structural integrity due to the infection and compromised the seal between the valve cuff and annulus.Pvl is a rare but recognized risk of prosthetic aortic valve replacement, as is the possibility of explantation [instructions for use].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 [iso 5840:2005).Root cause for this event is paravalvular leak secondary to infection.No further action is required at this time.

Event Description

According to implant registration cards, onxace-21 sn (b)(4) implanted (b)(6) 2011.Onxace-21 sn (b)(4) implanted (b)(6) 2017 same patient, same position.No alleged deficiency made to sn (b)(4).This complaint is relegated to sn (b)(4).Additional information from the surgeon is as follows, " this valve was replaced for paravalvular leak unlikely related to implant and more likely due to bacteraemia post-op.Valve explanted was in good nick [condition].Can't send you the operation report.Patient came through repeat surgery well.".

• 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: 7067806
• MDR Text Key: 93230284
• Report Number: 1649833-2017-00086
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/01/2017
• Date Manufacturer Received: 11/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR