MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE; MECHANICAL HEART VALVE

Model Number ONXACE

Device Problem Paravalvular leak(s) (1450)

Patient Problem Aortic valve replacement (2472)

Event Date 01/06/2015

Event Type  Injury  

Event Description

Paravalvular leak (pvl), intraoperative.Investigation of the returned valve shows no trouble found, and in reinspection of the valve construction and re-testing, valve meets spec.The investigation concluded the pvl is not the fault of the valve itself.However, the aats/sts guidelines (j.Thoracic and cardio vascular surgery - (b)(6) 2008) formally defines that pvl is valve-related, therefore, this event is being reported.Circumstances: when the pt was taken off bypass pump, the pvl condition was noted, so they went back on pump to correct the problem.No further info was provided to on-x.Pvl is an expected adverse event.Reported occurrences are well-within expected frequency.There is not trend evident.

Manufacturer Narrative

None of the conditions describe the problem the pvl was noted and corrected intra-operatively.Results: the valve was reinspected upon receipt to look for evidence in its construction that could possibly induce paravalvular leak.The sewing ring outflow surface had some cuts circumferentially that appear to be associated with cutting the sutures to free the valve when explanting.Otherwise, the sewing ring was examined to verify correct construction.It was concluded the sewing ring was properly build.These examinations were done to look for possible contribution to a pvl even that may result from anomaly in the sewing ring construction.This examination concluded that there were no such anomalies.As we did not have the benefit of examining the echo to evaluate the reported pvl, it is possible that the inherent leakage jets were misinterpreted as pvl or it may be that pvl was induced by the manner in which the valve was sutured in place or condition of tissue it was sutured to.The condition was presumably corrected in the implantation of the replacement valve.

• Brand Name: ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e anderson ln; bldg b; austin TX 78752
• Manufacturer Contact: walt moeller, dir qa/ra ; 1300 e anderson ln; bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 4508093
• MDR Text Key: 20774485
• Report Number: 1649833-2015-00001
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2018
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-23
• Other Device ID Number: 00851788001464
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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): Other