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

Model Number ONXAE

Device Problems Device remains implanted (1526); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/22/2012

Event Type  Death  

Manufacturer Narrative

The aats/sts guidelines devine valve-related mortality as reportable.Therefore, this is being reported.This is an expected adverse event and is occurring within expected rate.No trend is seen.No autopsy was done and valve not explanted.Review of device history records for this valve shows the valve was built per specifications.

Event Description

This is the second mdr for this double-valve replacement case.Most of the information is the same as in mdr # 1649833-15-17.Event occurred in (b)(6).10th post-op day, patient death.Judged as operative mortality, probably "sudden".Background: judged as operative mortality, probably "sudden".Background: double-valve patient.Disease etiology: endocarditis.Nyha class iii.Mitral regurgitation and aortic regurgitation.Emergency valve replacement, aortic and mitral.Patient not on anticoagulation on surgery date.On july 21, 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.There are no statistically significant differences in these rates and this trial was run at inr of 1.5 to 2.5 versus the pma at 2.0 to 3.0.At lower inr lo 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 ln.; bldg b; austin, TX 78752 ; 5123398000
• MDR Report Key: 5001655
• MDR Text Key: 23979786
• Report Number: 1649833-2015-00018
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001402
• UDI-Public: 00851788001402
• 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: 08/10/2015

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: 03/08/2016
• Device Model Number: ONXAE
• Device Catalogue Number: ONXAE-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR