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

Model Number ONXM

Device Problems Interference (1327); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

Waiting on arrival of valve.Then investigation will be done.It is expected that, as in all past investigations of leaflet motion problems, it will be shown that there is no trouble found.This initial mdr filed because the 30-day limit will transpire before investigation conclusions are in place.A f/u mdr will be prepared at that time.Review of device history records for this valve shows the valve was built per specs.

Event Description

Event occurred in (b)(6).On-x mitral valve was used in mitral valve replacement case.Echo check after surgery found severe mitral regurgitation.Surgeon thought it might be due to malfunction of the valve leaflet, not paravalvular leak.The valve was explanted and replaced.Dr.(b)(6) wanted to know if there is any problem with the explanted valve.The valve is being returned to on-x for investigation.

Event Description

This is a follow-up report to the original mdr (pre-emdr) no.(b)(6).Event occurred in china.Original report stated "on-x mitral valve was used in mitral valve replacement case.Echo check after surgery found severe mitral regurgitation.Surgeon thought it might be due to malfunction of the valve leaflet, not pvl.The valve was explanted and replaced with another on-x valve same model and size and that surgery was successful." the valve has been returned and retested, and was found to meet specifications.Tests for proper leaflet functionality all passed.Therefore, the reason for the leaflet motion problem on s/n (b)(6) was caused by unknown interference with leaflet motion, usually it is anatomical interference such as from retained mitral apparatus.We now know it was not a malfunction.

Manufacturer Narrative

None of the selections in h1 are applicable.The device did not malfunction, it was found to function per specs.In g4, the date rec'd by mfr is the original date received on the initial mdr.A final report of the investigation was prepared suitable for presentation to the surgeon who was asking for analysis as to whether there was malfunction.The final report is attached to this mdr.- attachment: [2015-37 final report of complaint investigation.Pdf].2015-37 final report of complaint investigation.Pdf.

• 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: 4999233
• MDR Text Key: 24076787
• Report Number: 1649833-2015-00021
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00851788001273
• UDI-Public: 00851788001273
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Not Applicable
• Report Date: 08/11/2015

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2019
• Device Model Number: ONXM
• Device Catalogue Number: ONXM-25
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male