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

Model Number ONXAE

Device Problem Insufficient Information (3190)

Patient Problem Aortic Regurgitation (1716)

Event Date 12/01/2011

Event Type  No Answer Provided  

Manufacturer Narrative

This is an untreated adverse event.Valve not explanted.It was decided to not treat the pvl.The valve is being left in the patient with the observation during follow-up visits that there is on-going pvl, w/moderate aortic regurgitation grade iii.

Event Description

Event occurred in (b)(6).Overall, patient disease etiology was "prosthetic valve dysfunction - calcific" and tissue fragility resulting from re-operation.Patient had a re-do aortic valve replacement using on-x valve, resulted in paravalvular leak (pvl), post-operative-early.Nyha class ii.It was decided to not treat the pvl.The valve is being left in the patient with the observation during follow-up visits that there is on-going pvl, w/ moderate aortic regurgitation grade iii.The aats/sts guidelines defines pvl as valve-related and is reportable.Therefore, this is being reported.This is an expected adverse event and is occurring within expected rate.On (b)(6) 2015, onxlti received a set of data from the sponsor of a (b)(6) post-market study, where-in they wanted on-x to do data analysis on a set of data containing adverse events.The valve on this mdr is one of the ae's.Once analyzed against the entire population in the (b)(6) study (only avr has enough data for proper analysis) and then comparing to the pma.There are no statistically significant differences in these rates and this trail was run at inr of 1.5 to 2.5 versus the pma at 2.0 to 3.0.At lower inr low rates are expected based on our research.So these events while mdr reportable as individual occurrences, they are overall in the range expected.

• Brand Name: ON-X AORTIC 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, director, qa/ra ; 1300 e. anderson lane, bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 5000655
• MDR Text Key: 23422326
• Report Number: 1649833-2015-00015
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,study
• Reporter Occupation: Not Applicable
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/27/2016
• Device Model Number: ONXAE
• Device Catalogue Number: ONXAE-25
• Other Device ID Number: 00851788001419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR