MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE, MECHANICAL

Model Number ONXMC-25/33

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial report, onxmc-25/33 sn (b)(4) was implanted on (b)(6) 2020 and replaced with onxmc-25/33 on (b)(6) 2020.

Manufacturer Narrative

No additional information was received.The manufacturing records for serial number (b)(6) 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.Onxmc-25/33 sn (b)(6) was implanted in the mitral position of a (b)(6) female patient on (b)(6) 2020.Only 45 days later, on (b)(6) 2020, this valve was explanted and replaced with another on-x mitral valve of the same model and size.No other information was provided to explain this replacement.Consequently, we do not have enough information to know what, if any, contribution the valve had to the decision to explant and replace sn (b)(6).The instructions for use (ifu) for the on-x valve lists the possibility of reoperation and/or explantation as a consequence of a complication of prosthetic heart valve replacement.But in this instance, we do not have any evidence to identify that complication.This event does not identify additional hazards or modify the probability and severity of existing hazards.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: ONX MITRAL CONFORM 25/33
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• MDR Report Key: 10010023
• MDR Text Key: 191405338
• Report Number: 1649833-2020-00011
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2020
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 04/09/2020
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR