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

Model Number ONXACE

Device Problems Break (1069); Leaflet fracture (2413)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

The available response does not describe the problem.The valve was broken due to user error (iatrogenic).Not a failure in service.Valve is being returned, has not arrived yet.Detailed investigation is planned and resulting info will be provided in a f/u report.Review of device history records for this valve shows the valve was built per specs.

Event Description

Event occurred in (b)(6).One leaflet broke into 2 pieces, intra-operatively.Know to be iatrogenic.No adverse effect on the pt.Further info will be provided in a f/u report after detailed investigation.

• Brand Name: ON-X AORTIC PROSTHETIC HEART VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson n; bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 8200 cameron rd., a-196; austin TX 78754
• Manufacturer Contact: walt moeller, dir ; 1300 e. anderson ln, bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 4999230
• MDR Text Key: 24077504
• Report Number: 1649833-2015-00020
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001426
• UDI-Public: 00851788001426
• 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: company representative
• Reporter Occupation: Not Applicable
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/19/2019
• Device Model Number: ONXACE
• Device Catalogue Number: ONXACE-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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