MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC ONX MITRAL STANDARD 23; HEART-VALVE, MECHANICAL

Model Number ONXM-23

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Death (1802); No Information (3190); No Information (3190)

Event Date 11/23/2016

Event Type  Death  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Patient received sjm aortic and onx mitral valve on (b)(6).Patient suffered two arrests culminating in death on (b)(6).Cause of death is unknown at this juncture.

Manufacturer Narrative

The manufacturing records for the onxmc-23 sn (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.A review was performed of the available information.The onxm-23 sn (b)(4) implanted (b)(6) 2016 in the mitral position as part of a double valve replacement (dvr) procedure in which a st.Jude valve was implanted in the aortic position.The patient died the next day of unknown cause following two arrest episodes.Per the guidelines for reporting morbidity and mortality in cardiac valve interventions, this would be classified as an early sudden, unexplained death; a valve-related mortality [akins 2008].Although relatively rare, death is a recognized potential adverse event associated with heart valve replacement [instructions for use].For example, chambers, et al., reporting on a 12-year follow-up study of on-x patients, showed no early sudden deaths, but did have 3 out of 70 double valve recipients with cardiac related early deaths.As the cause is classified as an early sudden, unexplained death, we cannot, by definition, speculate on the cause of death.There is too little information to establish what, if any, relationship the on-x valve has to the event.No further action is warranted.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

Patient received sjm aortic and onx mitral valve on (b)(6) [2016].Patient suffered two arrests culminating in death on [(b)(6) 2016].Cause of death is unknown at this juncture.

• Brand Name: ONX MITRAL STANDARD 23
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson lane, bldg b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC; 1300 e. anderson lane, bldg b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 6206864
• MDR Text Key: 63357348
• Report Number: 1649833-2016-00082
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: MP
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXM-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/29/2016
• Date Manufacturer Received: 11/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death