MAUDE Adverse Event Report: ONX LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART VLAVE, 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 03/13/2020

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 the patient had onxmc 25/33 serial number: (b)(4) explanted on (b)(6) 2020, and replaced with onxmc 27/29.The onxmc 25/33 serial number: (b)(4) was implanted on (b)(6) 2019.The reason for explant of the onxmc valve is unknown.

Manufacturer Narrative

Please note the serial number in the following statement is incorrect: 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.The correct serial number is (b)(6).

Manufacturer Narrative

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.The onxmc-25/33 sn (b)(6) was implanted in the mitral position of a 38-year-old male on (b)(6) 2019 in a re-operation attributed to endocarditis.This action is detailed in report 1649833-2020-00076.A second re-operation was performed three months later, on 2020 mar 13, in which the sn (b)(6) was also explanted and replaced with an onxm-27/29 sn (b)(6).The reason for the latest explant and replacement was not shared by the site, only that there was no valve malfunction.The explanted valve was returned to the manufacturer.While the recurrence of endocarditis is a possibility, we do not have any evidence from the site that it is the cause of necessitating the 2nd re-operation.Consequently we do not have enough information to know what, if any, contribution the valve had to the decision to explant sn (b)(6).The instructions for use for the on-x valve lists the possibility of reoperation and/or explantation as a consequence of complication of prosthetic heart valve replacement [ifu].But in this instance, we do not have any evidence to identify that complication.There is not enough information to determine what, if any, contribution the on-x valve had to the decision for its removal.There were no issues found in the manufacture of the device.Theifu provides instruction about potential adverse events associated with the use of prosthetic heart valves which may lead to explantation and reoperation.The on-x risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

Additional information was received on 04/23/2020 via email from the surgeon's ma.The following information was provided "i received information regarding the email listed below.There was no valve malfunction.We cannot disclose any further information.Thank you.".

• Brand Name: ONX MITRAL CONFORM 25/33
• Type of Device: HEART VLAVE, MECHANICAL
• Manufacturer (Section D): ONX LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln.; building b; austin TX 78752
• MDR Report Key: 9890512
• MDR Text Key: 191403813
• Report Number: 1649833-2020-00006
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• 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
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 38 YR