MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER -23MM; MECHANICAL VALVE CONDUIT

Model Number ONXACE-23

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

Patient Problems Aortic Insufficiency (1715); Organ Dehiscence (2502)

Event Date 05/24/2016

Event Type  Injury  

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.Paravalvular leak (pvl) and associated insufficiency are known, but relatively rare, complications of prosthetic valve implantation.In a 10-year experience at a single center, 428 on-x implants (264 aortic and 164 mitral) resulted in two cases of pvl, both considered minor and requiring no intervention [(b)(6) 2007].In a european multicenter study, out of 691 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, 12 in the mitral, and 4 double valve cases [(b)(6) 2013].In a usa multicenter study with 142 aortic and 142 mitral cases followed for a mean of 4.5 years, only one case of late pvl (in the aortic position) was observed and it was repaired on re-operation [(b)(6) 2006].Pvl can result from three primary conditions: necrosed annular tissue, most commonly due to endocarditis, dehiscence of the sewing cuff (that is, the stitching was compromised), or improperly seated at surgery.Aortic insufficiency and pvl are known potential complications 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.Without return of the valve, a definitive root cause cannot be identified.

Event Description

Implant recovery cards received indicate that patient implanted with onxace-25 ((b)(4), valve 1) on (b)(6) 2015 indicated for aortic valve regurgitation and bacterial endocarditis.Re-intervention and explant required on (b)(6) 2015 for bacterial endocarditis, replaced with onxace-23 ((b)(4), valve 2).Additional re-intervention/explant required on (b)(6) 2015 indicated for "4+ aortic insufficiency with a rocking aortic valve suggesting dehiscence" and replaced with onxace-23 ((b)(4)).This report is relegated to valve 2.

• Brand Name: ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER -23MM
• 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: 5995206
• MDR Text Key: 56333666
• Report Number: 1649833-2016-10053
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001464
• UDI-Public: 00851788001464
• 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
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/15/2020
• Device Model Number: ONXACE-23
• 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; Other
• Patient Age: 37 YR