MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X ASCENDING AORTIC PROSTHESIS; MECHANICAL VALVE CONDUIT

Model Number ONXAAP-25

Device Problem Contamination (1120)

Patient Problem Endocarditis (1834)

Event Date 01/07/2014

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.Endocarditis is a known potential complication listed in the instructions for use (ifu).Furthermore, this complication is not unique to the on-x device and is a risk 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 implanted with onxace-19 and onxm-25 on (b)(6) 2009 and required intervention/explant on (b)(6) 2014 with replacement via onxace-21 and onxm-27/29 indicated for aortic and mitral prosthetic valve endocarditis with ascending aortic aneurysm.This report is relegated to the onxm-25 valve.A separate report is being submitted for the other valve.

Manufacturer Narrative

Note: the initial report for 1649833-2016-00016 submitted 09/16/2016 contained information for the wrong product and was updated in this follow-up report.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 proact 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.Endocarditis is a known potential complication listed in the instructions for use (ifu).Furthermore, this complication is not unique to the on-x device and is a risk 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 implanted with onxaap-25 on (b)(6) 2013 and required intervention/explant on (b)(6) 2014 and replacement with another onxaap-25 indicated for prostatic valve endocarditis with (b)(6), subvalvular aortic vegetation, and infected ascending aorta and hemiarch graft.Procedures performed were redo sternotomy, redo aortic root replacement with a 25-mm on-x mechanical valve conduit, redo ascending aorta and hemiarch repair with 26-mm hernashield graft, modified cabral with saphenous vein graft to right coronary ostium, endoscopic saphenous vein harvest, and placement of 2-catheter marcaine infusion pump.

Manufacturer Narrative

Note: the initial report for 1649833-2016-00016 submitted 09/16/2016 contained information for the wrong product and was updated in this follow-up report.Note 2: udi added.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 (b)(4).In the (b)(4) study for avr , there were (b)(4) reported cases out of (b)(4) implants [puskas 2014).Endocarditis of prosthesis is an infrequent, but known risk of aortic valve replacement using prosthetic heart valves.Endocarditis is a known potential complication listed in the instructions for use (ifu).Furthermore, this complication is not unique to the on-x device and is a risk 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 implanted with onxaap-25 on (b)(6)2013 and required intervention/explant on (b)(6) 2014 and replacement with another onxaap-25 indicated for prostatic valve endocarditis with (b)(6), subvalvular aortic vegetation, and infected ascending aorta and hemiarch graft.Procedures performed were redo sternotomy, redo aortic root replacement with a 25-mm on-x mechanical valve conduit, redo ascending aorta and hemiarch repair with 26-mm hernashield graft, modified cabral with saphenous vein graft to right coronary ostium, endoscopic saphenous vein harvest, and placement of 2-catheter marcaine infusion pump.

• Brand Name: ON-X ASCENDING AORTIC PROSTHESIS
• Type of Device: MECHANICAL VALVE CONDUIT
• 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: 5956034
• MDR Text Key: 54922936
• Report Number: 1649833-2016-00016
• 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,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 Model Number: ONXAAP-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• 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; Life Threatening; Other
• Patient Age: 59 YR