MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER - 19MM; MECHANICAL HEART VALVE

Model Number ONXACE-19

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Insufficiency (1715); Aortic Regurgitation (1716); Endocarditis (1834)

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Operated valve endocarditis is a recognized risk of prosthetic valves that could lead to thrombosis, thrombotic embolism, bleeding events, or paravalvular leak [akins 2008].The objective performance criteria of iso 5840 for rigid prosthetic valves indicates an endocarditis rate of 1.2 %/pt-yr.In the (b)(6) study for avr , there were 9 reported cases out of 375 implants [puskas 2014).Endocarditis of prosthesis is an infrequent, but known risk of aortic valve replacement using prosthetic heart valves.Prosthesis pannus, prosthesis regurgitation, and endocarditis are known potential complications listed in the instructions for use (ifu).Furthermore, these complications are not unique to the on-x device and are known risks associated with all mechanical heart valves.All observed risks are mitigated in the labeling and ifu.No further action required.

Event Description

Implant recovery cards received indicate that patient received onxace-19 on (b)(6) 2011 and required intervention/explant on (b)(6) 2015 and replacement via onxace-23.Operative notes indicate the following: diagnosed with "aortic regurgitation status post mechanical aortic valve" on (b)(6) 2015.Procedure [performed (b)(6) 2015]: reentry median sternotomy.Explantation of 19 mm on-x mechanical aortic prosthesis.Septal myomectomy.Mitral valve repair.A 28 mm cg annuloplasty band.Aortic valve replacement.A 25 mm on-x mechanical aortic prosthesis.Gore-tex patch enlargement of the annulus with extension out on to the anterior leaflet of the mitral valve.Intraoperative transesophageal echocardiography.This (b)(6) female who underwent implantation of a 19mm on-x valve by [surgeon] on (b)(6) 2011, the patient did relatively well, but did most likely experience a low-grade endocarditis, requiring long-term antibiotic therapy.The patient also subsequently required placement of a ddd transvenous pacemaker by [surgeon] for sick sinus syndrome in (b)(6) [2011].Because of further evaluation, she was found to have a significant gradient across her aortic prosthetic valve with possible pannus growth beneath the valve in the presence of a small 19 mm valve leading to patient prosthetic mismatch.She has also had severe left ventricular hype trophy leading to diastolic lv dysfunction.She is put forward at this time for redo aortic valve replacement.".

Manufacturer Narrative

In 2016, on-x technologies incorporated (on-x) became a wholly owned subsidiary of cryolife, inc.(cryolife).A retrospective review of the on-x complaint system was performed to identify any areas requiring additional action and to appropriately assimilate the on-x process into the cryolife quality management system.In an abundance of caution this mdr is being reported to satisfy regulatory reporting obligations.Operated valve endocarditis is a recognized risk of prosthetic valves that could lead to thrombosis, thrombotic embolism, bleeding events, or paravalvular leak [akins 2008].The objective performance criteria of iso 5840 for rigid prosthetic valves indicates an endocarditis rate of 1.2 %/pt-yr.In the (b)(6) study for avr , there were 9 reported cases out of 375 implants [puskas 2014).Endocarditis of prosthesis is an infrequent, but known risk of aortic valve replacement using prosthetic heart valves.Prosthesis pannus, prosthesis regurgitation, and endocarditis are known potential complications listed in the instructions for use (ifu).Furthermore, these complications are not unique to the on-x device and are known risks associated with all mechanical heart valves.All observed risks are mitigated in the labeling and ifu.No further action required.

Event Description

Implant recovery cards received indicate that patient received onxace-19 on (b)(6) 2011 and required intervention/explant on (b)(6) 2015 and replacement via onxace-23.Operative notes indicate the following: diagnosed with "aortic regurgitation status post mechanical aortic valve" on (b)(6) 2015.Procedure [performed (b)(6) 2015]: reentry median sternotomy.Explantation of 19 mm on-x mechanical aortic prosthesis.Septal myomectomy.Mitral valve repair.A 28 mm cg annuloplasty band.Aortic valve replacement.A 25 mm on-x mechanical aortic prosthesis.Gore-tex patch enlargement of the annulus with extension out on to the anterior leaflet of the mitral valve.Intraoperative transesophageal echocardiography.This (b)(6) female who underwent implantation of a 19mm on-x valve by [surgeon] on (b)(6) 2011, the patient did relatively well, but did most likely experience a low-grade endocarditis, requiring long-term antibiotic therapy.The patient also subsequently required placement of a ddd transvenous pacemaker by [surgeon] for sick sinus syndrome in (b)(6) of this year [2011].Because of further evaluation, she was found to have a significant gradient across her aortic prosthetic valve with possible pannus growth beneath the valve in the presence of a small 19 mm valve leading to patient prosthetic mismatch.She has also had severe left ventricular hypertrophy leading to diastolic lv dysfunction.She is put forward at this time for redo aortic valve replacement.".

• Brand Name: ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER - 19MM
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5956023
• MDR Text Key: 54926104
• Report Number: 1649833-2016-00012
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Model Number: ONXACE-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR