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 Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

Hospital states "defective valve".No other info has bee provided,so no investigation is possible until and unless valve is returned to onxlti.Intra-operative, no known effect on pt.

Manufacturer Narrative

The device has not been returned.Currently trying to get it back for investigation.If relevant further info 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: wlater moeller, dir ; 1300 e anderson ln; bldg b; austin, TX 78754 ; 5123398000
• MDR Report Key: 4176964
• MDR Text Key: 5019881
• Report Number: 1649833-2014-00011
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2018
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-21
• Other Device ID Number: 00851788001457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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