MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 19; HEART VALVE MECHANICAL

Model Number ONXACE-19

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

Patient Problems Endocarditis (1834); Valvular Stenosis (2697)

Event Date 01/22/2018

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 initial reports, implant registration cards were received for onxace-27/29 serial number (b)(4), implant date (b)(6) 2018 and onxace-19 serial number (b)(4), implant date (b)(6) 2014.The following information was obtained via operative notes provided by the surgeon's office.Diagnoses: prosthetic valve endocarditis with aortic root abscess status post 2 prior aortic valve replacement operations.History of native valve endocarditis status post aortic valve replacement with 21 mm pericardial valve in 2013.History of prosthetic valve endocarditis of pericardial valve status post redo sternotomy and redo aortic valve placement with 19 mm on-x mechanical valve in 2014.History of intravenous drug abuse.History of hepatitis c.Operations performed: redo redo sternotomy.Aortic root replacement with a self-constructed 27-29 on-x/32 mm valsalva mechanical valve conduit with primary coronary reattachment.Explantation of old 19 mm on-x mechanical valve.The 22 modifier for above procedure.Indication for procedure: this (b)(6) year-old gentleman has a complex history of aortic valve surgery.He had aortic valve replacement with a pericardial valve in 2013 for native valve endocarditis.He developed prosthetic valve endocarditis in 2014 and had a redo sternotomy on-x mechanical valve.He had been doing well until several weeks ago when he had a relapse in his drug habits.Ultimately, this led to infection of his current valve with a root abscess.It was felt that surgical intervention would be necessary at this time.

Event Description

According to initial reports, implant registration cards were received for onxace-27/29 serial number (b)(4), implant.Date (b)(6) 2018 and onxace-19 serial number (b)(4), implant date (b)(6) 2014.The following information was obtained via operative notes provided by the surgeon's office.Diagnoses: prosthetic valve endocarditis with aortic root abscess status post 2 prior aortic valve replacement operations.History of native valve endocarditis status post aortic valve replacement with 21 mm pericardial valve in 2013.History of prosthetic valve endocarditis of pericardial valve status post redo sternotomy and redo aortic valve placement with 19 mm on-x mechanical valve in 2014.History of intravenous drug abuse.History of hepatitis c.Operations performed: redo redo sternotomy.Aortic root replacement with a self-constructed 27-29 on-x/32 mm valsalva mechanical valve conduit with primary coronary reattachment.Explantation of old 19 mm on-x mechanical valve.22 modifier for above procedure.Indication for procedure: this 30-year-old gentleman has a complex history of aortic valve surgery.He had aortic valve replacement with a pericardial valve in 2013 for native valve endocarditis.He developed prosthetic valve endocarditis in 2014 and had a redo sternotomy on-x mechanical valve.He had been doing well until several weeks ago when he had a relapse in his drug habits.Ultimately, this led to infection of his current valve with a root abscess.It was felt that surgical intervention would be necessary at this time.

Manufacturer Narrative

The manufacturing records for the onxace-19 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.A review of the information was performed.A 26.67 year old man implanted with onxace-19, sn (b)(4), on (b)(6) 2014 and required an intervention explant on (b)(6) 2018 (-3 years 7 months postop) indicated for, according to op notes, prosthetic valve endocarditis with aortic root abscess status post (s/p) 2 prior aortic valve replacements (avrs).The valve was replaced with a ¿self-constructed 27-29 on-x (onxace-27/29 sn (b)(4) 32mm valsalva mechanical valve conduit with primary coronary reattachment.A history of native valve endocarditis s/p avr with 21mm pericardial valve in 2013.A history of prosthetic valve endocarditis of pericardia valve s/p redo sternotomy and redo aortic valve placement with previously mentioned onxace-19.A history of intravenous drug use and hepatitis c.Operative notes indicate "he had been doing well until several weeks ago when he had a relapse in his drug habits.Ultimately, this led to infection of his current valve with a root abscess" and "also developed severe stenosis across his valve.¿ intravenous drug use increases the risk of infective endocarditis (ie).Reinfection occurrence is high as continued drug use seems to be a major challenge for this group.Additionally, previous episodes of ie increase the risk of a new incident [0sterdal2016].Additionally, chronic liver disease increases the susceptibility to bacterial infections and ie [perez de isla l 2003].Op notes indicate that procedure performed with "considerable difficulty because of the distortion of the anatomy" due to adhesions from two prior operations, aortic root abscess and subsequent induration and inflammation from the infection.These combined factors would likely contribute to the reported "severe stenosis." the instructions for use recognize endocarditis as a potential adverse event with subsequent reoperation, including explantation [ifu].Root cause for the reported event is complicated patient comorbidities including history of repeat cases of infective endocarditis, intravenous drug use, and chronic liver disease, unrelated to the on-x valve.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 19
• 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: 7331611
• MDR Text Key: 102187863
• Report Number: 1649833-2018-00008
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/16/2018
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 30 YR