MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER 27/29; HEART VALVE MECHANICAL

Model Number ONXACE-27/29

Device Problems Perivalvular Leak (1457); Insufficient Information (3190)

Patient Problems Endocarditis (1834); Organ Dehiscence (2502); No Code Available (3191)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Onxace 27/29 (sn (b)(4)) implanted on (b)(6) 2016 and required intervention/explant on (b)(6) 2016 and replaced with an onxae 25 (b)(4).

Manufacturer Narrative

The manufacturing records for the onxace-27/29 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 available information was performed.The onxace-27/29 sn (b)(4) was implanted (b)(6) 2016, then explanted and replaced by onxae-25 sn (b)(4) on (b)(6) 2016 (225 days postop) due to a paravalvular leak (pvl).The operative report describes dehiscence (separation of valve cuff from annulus tissue) of 80% of the circumference.There was tissue damage due to infection (endocarditis) that required extensive debridement and reconstructive efforts including bovine patch.In addition, a mitral prosthesis was implanted (onxm-31/33 sn (b)(4)) as suspected infection was found on the anterior leaflet of the native mitral valve.This is a case of paravalvular leak due to endocarditis (infection) that created a deterioration of the annular tissue to which the valve cuff was attached.It is a repeated experience for this patient who went through the explant/implant process on (b)(6) 2016.Pvl and endocarditis are known risks for aortic valve replacement surgery.Both are listed as potential adverse events in the on-x valve instructions for use.Objective performance criterion report a rate of all pvl of 1.2 %/patient-year, major pvl of 0.6%/patient-year, and endocarditis also at 1.2 %/patient-year (iso 5840:2005].In clinical trials, late (>30 days) occurrence of 1major pvl was observed in a study of 142 aortic on-x patients [mcnicholas 2006].Another study of 184 aortic on-x patients reported 5 late pvls, of which 2 were major [palatianos 2007].The root cause for this event is paravalvular leak subsequent to deterioration of aortic valve annular tissue attributed to endocarditis.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

Implant registration cards received indicate onxace 27/29 (sn (b)(4)) implanted on (b)(6) 2016 and required intervention/explant on (b)(6) 2016 and replaced with an onxae 25 ((b)(4)).This investigation is relegated to the onxace 27/29 (sn (b)(4)).

• Brand Name: ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER 27/29
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson ln.; bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 6227157
• MDR Text Key: 64010059
• Report Number: 1649833-2017-00001
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/09/2016
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/05/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 49 YR