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

Model Number ONXM

Device Problems Interference (1327); Valve(s), sticking (1673)

Patient Problems Rheumatic Heart Disease (2053); Thrombosis (2100); Heart Failure (2206)

Event Date 01/29/2014

Event Type  Injury  

Event Description

Patient with on-x mitral valve replacement (mvr) presented with valve thrombosis, cardiac failure, moderate rheumatic aortic regurgitation, and nyha class ii-iii.Patient is (b)(6), is known to be non-compliant with anticoagulation therapy.Re-operation performed, re-do mvr due to stuck mitral prosthesis (posterior leaflet).Aortic valve replacement also done.Intra-operatively, surgeon confirmed thrombus on the mitral valve.Patient recovered from the surgery.Valve thrombosis is by definition in the aats/sts guidelines a valve-related event and is therefore reportable.Valve thrombosis is an expected adverse event, as defined in the objective performance criteria in fda heart valve guidance, and iso 5840, and this occurrence is well-within expected rate.Correction of the event required re-operation, classified as a "serious injury".Therefore, it is reportable as an mdr.

Manufacturer Narrative

Device was evaluated by an independent surgeon who confirmed that the material on the valve blocking the leaflet function was thrombus.Photos were provided.In addition, full operative notes were provided stating the surgeon's analysis of the condition.It was decided that this eval was sufficient and the valve did not need to be returned.

• Brand Name: ON-X MITRAL 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 (Section G): ON-X LIFE TECHNOLOGIES, INC.; 8200 cameron rd., a-196; austin TX 78754
• Manufacturer Contact: walt moeller, director, qa/ra ; 1300 e anderson lane; bldg b; austin, TX 78754 ; 5123398000
• MDR Report Key: 3678939
• MDR Text Key: 21805430
• Report Number: 1649833-2014-00004
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/20/2014
• Device Model Number: ONXM
• Device Catalogue Number: ONXM-31/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR