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

Model Number ONXM

Device Problem Mechanical Problem (1384)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Not yet established that this is a device malfunction.This event is being reported because we have not yet received the returned valve for investigation.The conclusion is expected to be that this will be a case where the device and patient anatomy are not compatible.It is apparent that patient anatomy was interfering with leaflet motion.When the device is returned it will be retested.In all past cases of this type of complaint, the device had been found to function according to specs.I.E., no malfunction.A follow-up mdr will be files once we have the conclusion.Have not yet received the device.

Event Description

Patient received a mitral valve replacement (mvr) on (b)(6) 2015.Successfully implanted and tested the valve, all successful.After closure, noted that heart was ballooning, put patient back on bypass, found that a leaflet was not moving properly.Explanted that valve (onxm-27/29) and replaced with the only available valve, a size 25mm.Surgeon requested that we investigate.No other information available.Serial number not available.It is expected that the valve will be returned for investigation.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• Type of Device: MECHANICAL HEART VALVE
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; building b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TEHCNOLOGIES, INC.; 1300 e. anderson ln; bldg b; austin TX 78752
• Manufacturer Contact: walt moeller ; 1300 e. anderson ln; bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 5208358
• MDR Text Key: 30890802
• Report Number: 1649833-2015-70027
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001280
• UDI-Public: 00851788001280
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ONXM
• Device Catalogue Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention