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

Model Number ONXM

Device Problem Device remains implanted (1526)

Patient Problems Thrombosis (2100); Treatment with medication(s) (2571)

Event Date 03/06/2014

Event Type  No Answer Provided  

Event Description

Event occurred in (b)(6).Valve thrombosis, post-operative - late.The adverse event was first discovered in a journal article, (b)(6).The article makes the point that the thrombus on the stuck-closed leaflet could not be detected by tte, but could by using multidetector-row computed tomography.On (b)(6) 2015, onxlti received a set of date from the sponsor of a (b)(6) post-market study, where-in they wanted on-x to do data analysis on a set data containing adverse events.The valve on this mdr is one of the ae's.The thrombosis was corrected by thrombectomy via arterial shunt.Inr on date of event was subtherapeutic at 1.4.Valve thrombosis is by definition in the aats/sts guidelines a valve-related event and is therefore, reportable.It 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.

Manufacturer Narrative

The valve remains implanted and functioning normally.The valve was not explanted so no serious injury, the valve had 1 leaflet stuck closed due to the thrombus, which was corrected medicinally, using thrombectomy administered via arterial shunt.Review of factory device history records shows the device was built per specs.

• 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 ln, bldg b; austin TX 78752
• Manufacturer Contact: walt moeller, dir ; 1300 e. anderson ln, bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 4962992
• MDR Text Key: 6193775
• Report Number: 1649833-2015-00012
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Distributor
• Type of Report: Initial
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2015
• Device Model Number: ONXM
• Device Catalogue Number: ONXM-31/33
• Other Device ID Number: 00851788001297
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2010
• 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): Other; Required Intervention
• Patient Age: 62 YR