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

Device Problems Device remains implanted (1526); Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/31/2013

Event Type  Death  

Manufacturer Narrative

Clinical center stated this event is not valve-related, was classified as "other-cardiovascular".However, the aats/sts guidelines defines sudden unexplained death as a valve-related mortality and is reportable.Therefore, this is being reported.Valve not explanted and no autopsy.

Event Description

Event occurred in (b)(6).Overall, patient disease etiology was ischemic heart disease.Patient classified as avr high risk.Sudden death on (b)(6) 2013, post-operative - late.Inr on date of event was 1.6, nyha class i, cardiac condition was sinus rhythm.No autopsy, valve not explanted.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.(b)(6).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: 5001651
• MDR Text Key: 23978757
• Report Number: 1649833-2015-00014
• 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
• 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: 58 YR