MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX AORTIC CONFORM EXT 21; HEART VALVE MECHANICAL

Model Number ONXACE-21

Device Problem Insufficient Information (3190)

Patient Problems Embolism (1829); Fungal Infection (2419); Pseudoaneurysm (2605)

Event Date 01/09/2018

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 initial reports: "four months after elective aortic valve replacement/root enlargement [onxace-21, (b)(4)] was performed on a young adult, the patient required repeat surgery for a pseudoaneurysm of the ascending aorta and a small perivalvular abscess.Vegetation was noted to be attached to the previously implanted bovine pericardium which had broken down and shriveled into a clump of tissue in the mid anterior wall of the aorta.This bovine graft material was removed, cultured, and grew aspergillus.The source of the aspergillus is suspected to have been introduced from the air during implantation.However, out of an abundance of caution, this report is being submitted.Patient had embolic splenic infarcts 2 months prior to redo sternotomy and renal infarct afterward.Endocarditis.Patient experienced blood loss, ards, ruptured aorta and died several weeks later." implant date - (b)(6) 2017, date of event - (b)(6) 2017.

Manufacturer Narrative

The manufacturing records for the onxace-21 sn (b)(4) 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.During the investigation no non-conformances or deviations were noted.A review was performed of the available information.The onxace-21 sn (b)(4) heart valve was reported as implanted (b)(6) 2017 in the aortic position of a (b)(6) female.A medwatch report from the hospital yielded the following information: the patient had pre-existing hepatic/renal dysfunction and was morbidly obese.The valve replacement surgery also involved aortic root enlargement during which a synovis® bovine pericardial patch was used.Approximately two months post-surgery, the patient experienced splenic infarcts.Approximately four months post-surgery a redo operation was performed for repair of pseudoaneurysm of the ascending aorta and perivalvular abscess.The patch had deteriorated and was removed.Culture of the tissue yielded aspergillus.The source was attributed to air during implantation.Subsequent to the redo surgery, the patient experienced renal infarct, endocarditis, blood loss, acute respiratory distress syndrome (ards), and ruptured aorta.The patient died a few weeks later.The exact date was not specified.The clinical evidence provided indicates the underlying cause of the series of complications is failure of the aorta, weakened by infection thought to be introduced by airborne pathogens during the initial aortic valve replacement and root enlargement surgery.Furthermore, onxace undergoes a validated terminal sterilization step during processing making it unlikely the reported clinical findings are related to implantation of a contaminated on-x valve.Infection is a known risk of prosthetic valve replacement [on-x instructions for use].It is also recognized as a risk of the bovine patch material along with tissue degeneration (peri-guard instructions for use].Objective performance criteria (opc) report a historical rate of endocarditis for rigid prosthetic valves at 1.2 %/patient-year [iso 5840:2005].The root cause for the death of the patient was a ruptured aorta weakened by infection.There is no indication that the on-x valve contributed to the outcome.No further action is required at this time.

Event Description

According to initial reports: "four months after elective aortic valve replacement/root enlargement [onxace-21, sn (b)(4)] was performed on a young adult, the patient required repeat surgery for a pseudoaneurysm of the ascending aorta and a small perivalvular abscess.Vegetation was noted to be attached to the previously implanted bovine pericardium which had broken down and shriveled into a clump of tissue in the mid anterior wall of the aorta.This bovine graft material was removed, cultured, and grew aspergillus.The source of the aspergillus is suspected to have been introduced from the air during implantation.However, out of an abundance of caution, this report is being submitted.Patient had embolic splenic infarcts 2 months prior to redo sternotomy and renal infarct afterward.Endocarditis.Patient experienced blood loss, ards, ruptured aorta and died several weeks later." implant date - (b)(6) 2017, date of event - (b)(6) 2017.

• Brand Name: ONX AORTIC CONFORM EXT 21
• Type of Device: HEART VALVE MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer (Section G): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln., bldg. b; austin TX 78752
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144
• MDR Report Key: 7176359
• MDR Text Key: 96818343
• Report Number: 1649833-2018-00099
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXACE-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/21/2017
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 33 YR