MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING; HEART-VALVE, MECHANICAL

Model Number ONXM-27/29

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

Patient Problem Thrombosis (2100)

Event Date 05/06/2019

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, "we have been advised by [surgeon] that they are operating on a patient with a clotted on-x valve, original valve done in 2013.We are arranging to collect the valve from the hospital.".

Manufacturer Narrative

The manufacturing records for the onxm-27/29 sn (b)(6) were reviewed by 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.Report states ¿we have been advised by [surgeon] that they are operating on a patient with a clotted on-x valve, original valve done in 2013.We are arranging to collect the valve from the hospital.¿ according to a letter received from [distributor], ¿thank you for returning the valve and for the photographs.[distributor doctor] looked at the valve and the photographs.The photographs showed large organized and organizing clots.The valve was normal with free movement of the leaflets and there was no clot in the valve itself.Although your operation notes does not record it the valve obstruction was presumably related to atrial clot obstructing a normal valve as we sometimes see with atrial myxomas.¿ patient implanted with mitral valve on (b)(6) 2013 for associated mitral valve disease and explant/replacement procedure was conducted on (b)(6) 2019 approximately 5.5 years post implant.Specific location of the thrombus cannot be ascertained from the available information.The valve required explant due to ¿clotted on-x valve¿ but analysis by [distributor doctor] indicated ¿the valve was normal with free movement of the leaflets and there was no clot in the valve itself.¿ a picture provided only shows free clot removed from the valve.Additionally, inr [international normalized ratio] at time of event is unknown, nor do we have any information pertaining to anticoagulation compliance, concomitant medications, diet, or comorbid conditions.Thrombosis is a rare, but expected complications associated with prosthetic mechanical heart valves [instructions for use] and is not unique to the on-x valve.Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves [iso 5840:2005].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.

Event Description

According to the initial report, "we have been advised by [surgeon] that they are operating on a patient with a clotted on-x valve, original valve done in 2013.We are arranging to collect the valve from the hospital.".

• Brand Name: ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING
• 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: 8672961
• MDR Text Key: 147165094
• Report Number: 1649833-2019-00034
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: ONXM-27/29
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/06/2019
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other