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 Break (1069)

Patient Problem Aortic valve replacement (2472)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

During implantation, a 2 mm piece of the carbon housing was broken.The 2 mm piece was removed.The valve was explanted and a new/different valve was implanted in its place.The 2 mm piece was discarded at the hospital.The valve housing is being investigated for fracture analysis at an independent lab to determine the origin and potential cause of the crack.This is an initial report.Carbon part breakage is separately tracked to ensure no trends or systemic assignable cause.Currently, all have occurred intra-operatively and root cause for all have been known or shown to be iatrogenic in nature, and not due to product defect or malfunction.Such breakage has occurred at a recurrence rate of about 65 ppm.There will be a follow up after manufacturer's investigation.Per distributor-provided information, the patient is in good condition after the surgery, without any complications.

Manufacturer Narrative

Valve has been returned, investigation not yet completed.In all past cases of carbon part breakage, the investigation conclusion was "iatrogenic", ie, some sort of improper, rough treatment of the valve.There has been no structural dysfunction of failure of the on-x prosthetic of the investigation is expected to be similar to that in the past.When relevant further information becomes available, a follow-up mdr will be filed.

• 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, director ; 1300 e. anderson ln.; bldg b.; austin, TX 78752 ; 5123398000
• MDR Report Key: 4260745
• MDR Text Key: 5030103
• Report Number: 1649833-2014-00014
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2019
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-25
• Other Device ID Number: 00851788001471
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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