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

Model Number ONXMC

Device Problem Interference (1327)

Patient Problem Thrombosis (2100)

Event Date 03/31/2015

Event Type  Injury  

Event Description

Patient with on-x mitral valve replacement (mvr) presented with valve thrombosis.Per operative notes: clotted valve - patient symptom - cardiac failure (lcos - low cardiac output syndrome).Patient had stopped taking warfarin, lost her hospital card.No evidence of pannus.Corrective procedure was re-do mvr with onxm-25.Valve thrombosis is by definition in the (b)(4) 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.No trend is seen.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 the surgeon who confirmed that the material on the valve blocking the leaflet function was thrombus.In addition, full operative notes were provided stating the surgeon's analysis of the condition.The explanted valve was evaluated by dr (b)(6) who also provided photos.It was decided that these evaluations were 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.; 130 0e. anderson ln, bldg b; austin TX 78752
• Manufacturer Contact: walt moeller, director qa/ra ; 1300 e. anderson ln, bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 4861448
• MDR Text Key: 5862021
• Report Number: 1649833-2015-00007
• 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: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2018
• Device Model Number: ONXMC
• Device Catalogue Number: ONXMC-25/33
• Other Device ID Number: 00851788001303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR