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 Death (1802)

Event Date 06/08/2019

Event Type  Death  

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, patient was implanted with onxmc-25/33 sn (b)(4) on (b)(6) 2019 and passed away on (b)(6) 2019.

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.An onxmc-25/33, sn (b)(6), was implanted on (b)(6) 2019 in the mitral position in a 51-year-old female patient.While screening for participation in a clinical trial, the investigational site indicated the patient was deceased.An obituary was found online that indicated a date of death of (b)(6) 2019 (23 days post-implant).The mitral valve replacement operative report was made available.Per the operative report, the patient was presented ¿with critical mitral stenosis with a transmitral gradient of over 15 mmhg in the setting of severe end-stage rheumatic mitral valve stenosis, complicated by significant right ventricular failure.¿making this case of markedly augmented complexity was particularly due to her significant right ventricular failure.Furthermore, induction of nitric oxide in the operating room for a very severely dilated right ventricle was performed.The mitral valve was heavily calcified, requiring not only valvular, but also additional subvalvular resection.The post mitral valve replacement right ventricular dysfunction required extra time to carefully wean from cardiopulmonary bypass on inotropic support as well as nitric oxide.Collectively, these increased operative time by approximately 90 minutes.¿ nevertheless, ¿the valve was tested and found to be free of any perivalvular defects and none were found.¿ the patient was transferred to the intensive care unit in stable condition.¿ while the operative report indicates a successful surgery, we do not have a discharge summary nor any other post-surgical information with the exception of the obituary.Consequently, we do not know whether the patient was ever discharged from the hospital, no do we have any post-operative diagnosis with the result that we have no evidence to indicate what, if any, contribution the valve had to the death of the patient.Although there is no evidence of valve involvement, the instructions for use for the on-x valve lists death as a possible complication for mechanical heart valve replacement [ifu].There is insufficient information to indicate a root cause for the death of this on-x patient.There is no indication that the death is valve related.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: 9757919
• MDR Text Key: 181087309
• Report Number: 1649833-2020-00092
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR