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

Model Number ONXAC

Device Problem Paravalvular leak(s) (1450)

Patient Problems Aortic Regurgitation (1716); Aortic valve replacement (2472)

Event Date 05/26/2015

Event Type  Injury  

Event Description

Paravalvular leak (pvl), post-operative (late).Investigation of the returned valve shows no trouble found.The investigation concludes the pvl is not the fault of the valve itself.Surgeon operative notes states the valve was dehisced in an 8mm region associated with the pvl (i.E., sewing ring not securely sutured to the surrounding tissue).The valve sewing ring was otherwise well healed-in.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.Re-do-aortic replacement (avr) surgery defined to be "serious injury", therefore another reason to be reported.Pvl is an expected adverse event.Reported occurrences are well-within expected frequency.There is no trend evident.

Manufacturer Narrative

Results: the valve was reinspected upon receipt to look for evidence it its construction that could possibly induce paravalvular leak.The sewing ring edges 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 built.These examinations were done to look for possible contribution to a pvl event that may result from anomaly in the sewing ring construction.This examination concluded that there were no such anomalies.It is known from the surgeon'[s operative notes that there was an 8mm length of dehiscence in the area of the pvl.This is referring to the valve not being securely sutured on that 8mm length.This is believed to be the reason for the pvl.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.; 8200 cameron rd., a-196; austin TX 78752
• Manufacturer Contact: walt moeller, dir. qa/ra ; 1300 e. anderson ln.; bldg. b; austin, TX 78752 ; 5123398000
• MDR Report Key: 4894187
• MDR Text Key: 6540458
• Report Number: 1649833-2015-00010
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/01/2015

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: Lay User/Patient
• Device Expiration Date: 09/17/2012
• Device Model Number: ONXAC
• Device Catalogue Number: ONXAC27-29
• Other Device ID Number: 00851788001365
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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
• Patient Age: 53 YR