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 Device remains implanted (1526)

Patient Problem Aortic valve replacement (2472)

Event Date 06/04/2015

Event Type  No Answer Provided  

Event Description

Arterial clot in left leg.On (b)(6) 2015 patient noted numbness and cold in left leg.Patient went to work the following day and leg became painful so she was taken to the emergency room.Clot in left leg behind knee was found and the patient was taken to a hospital where medical treatment to dissolve the clot was tried for 12 hours.This was not successful so an arterial thrombectomy was performed.The valve remains implanted and functioning normally.The patient has recovered and self-reported this event.It is a possible thromboembolism and possibly related to the valve.

Manufacturer Narrative

The valve remains implanted and functioning normally.None of the conditions describe the problem.The arterial clot in the leg was surgically corrected.

• 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 lane, bldg. b.; austin TX 78754
• Manufacturer Contact: walt moeller, director qa/ra ; 1300 e. anderson lane, bldg. b; austin, TX 78754 ; 5123398000
• MDR Report Key: 4894034
• MDR Text Key: 20071386
• Report Number: 1649833-2015-00011
• Device Sequence Number: 1
• Product Code: LWQ
• 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: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2013
• 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: 06/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR