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

Model Number ONXAAP-23

Device Problem Insufficient Information (3190)

Patient Problems Complaint, Ill-Defined (2331); No Information (3190); No Code Available (3191)

Event Date 08/10/2016

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 the implant recovery card, patient implanted with onxaap-23 (b)(4) on (b)(6) 2016 which required explant on (b)(6) 2016 and replacement with another onxaap-23 as well as placement of a onxm-27/29.

Manufacturer Narrative

According to the implant registration cards (irc) submitted on 08/18/2016, a patient was implanted with an ascending aortic prosthesis (onxaap-23, sn (b)(4)) on (b)(6) 2016 which required explant on (b)(6) 2016 and replacement with another onxaap-23.Operative notes were received.Indications for reoperation include "mitral and aorotic valve prosthetic endocarditis in aortico-mitral curtain abscess, pseudoaneurysm, tricuspid valve, annuloplasty ring abscess and pacing wire abscess, endocarditis" performed via "mitral, aortic valve replacement, reconstruction of curtain, tricuspid valvuloplasty, closure aortic-ra fistula axillary cannulation and repair, redo, removal 8 sternal wires, removal of pacing wires and generator." the manufacturing records for the onxaap-23, 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.The onxaap-23 was implanted (b)(6) 2016 and was explanted and replaced (b)(6) 2016 (0.54 years postoperatively).The reoperative report clearly states cause of failure is extensive endocarditis to the point that "the valve was being held essentially by two stitches." 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) pt-yr.In the proact study for avr, there were (b)(4) reported cases out of (b)(4) implants [puskas 2014].Deterioration of annular tissue due to extensive endocarditis led to insecure attachment of the valve to the heart.

Event Description

According to the implant recovery card, patient implanted with onxaap-23 ((b)(4)) on (b)(6) 2016 which required explant on (b)(6) 2016 and replacement with another onxaap-23 as well as placement of a onxm-27/29.

• 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: 5910860
• MDR Text Key: 53390919
• Report Number: 1649833-2016-00045
• 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: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 07/01/2019
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• 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: 36 YR