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

Model Number ONXAAP-21

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Aortic Dissection (2491); Pericardial Effusion (3271)

Event Date 08/06/2018

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 the initial report and implant registration card received, a size 21 on-x ascending aortic prosthesis (onxaap-21), serial (b)(4) was implanted into a patient on (b)(6) 2018."pt [patient] died" was written on the implant registration card.Additional information was received via operative notes.The operative notes indicate that the patient presented with chest pain and was diagnosed with ascending aortic dissection.Preoperatively, the patient was neurologically intact and had adequate pressures.Chest ct revealed ascending aortic dissection which began at the aortic valve, extended into the arch involving carotid vessels and down into the thoracic aorta to just below the renal arteries.Findings included approximately 400 ml of blood in the pericardial sac with clot.Dissection involved the right coronary artery which was avulsed from the avulsed from the ascending aorta and appeared to be the source of the intrapericardial bleed.During the operation, the valve was excised and replaced with onxaap-21, serial (b)(4).The patient was then weaned from cardiopulmonary bypass.Initially, there was poor contractility of the right heart, so the patient was placed back on cardiopulmonary bypass.The patient gained reasonable but not good contractility of the right heart.The patient's right heart continued to fail with progressively more hypotension.Medications and intracardiac massage were given.Right heart was never able to get into a functional state and the patient was pronounced dead.

Manufacturer Narrative

The manufacturing records for the onxaap-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.A review of the available information was performed.A (b)(6) woman implanted via emergent procedure with onxaap-21, sn (b)(4), on (b)(6) 2018 indicated for ascending aortic dissection subsequently died same day due to right side heart failure.Medical notes indicate "underwent bentall operation and saphenous vein graft to the right coronary artery.The patient had extensive pericardia i blood due to partial avulsion of the right coronary artery.Procedure was performed and the patient could not be weaned from cardiopulmonary bypass due to right heart failure and despite efforts with inotropic support.Right heart never was able to have good contractility and the patient was noted to have fixed and dilated pupils and was pronounced dead at 0739 hours." it is possible that the death was due to the emergent conditions necessitating surgery in the first place as well as the associated trauma of surgical repair, but there is no objective evidence to indicate what contribution, if any, the valve or the surgery had to the cause of death.The (b)(6) lists a predicted operative mortality of 4.0% for aortic valve replacement (avr) cases [edwards 2001].The cause of death was due to aortic dissection.There is no indication that on-x ascending aortic prosthesis contributed to the patient death.The instructions for use also lists death as a potential complication of prosthetic aortic valve replacement surgery.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the initial report and implant registration card received, a size 21 on-x ascending aortic prosthesis (onxaap-21), serial number (b)(4) was implanted into a patient on (b)(6) 2018."pt [patient] died" was written on the implant registration card.Additional information was received via operative notes.The operative notes indicate that the patient presented with chest pain and was diagnosed with ascending aortic dissection.Preoperatively, the patient was neurologically intact and had adequate pressures.Chest ct revealed ascending aortic dissection which began at the aortic valve, extended into the arch involving carotid vessels and down into the thoracic aorta to just below the renal arteries.Findings included approximately 400ml of blood in the pericardial sac with clot.Dissection involved the right coronary artery which was avulsed from the avulsed from the ascending aorta and appeared to be the source of the intrapericardial bleed.During the operation, the valve was excised and replaced with onxaap-21, serial number (b)(4).The patient was then weaned from cardiopulmonary bypass.Initially, there was poor contractility of the right heart, so the patient was placed back on cardiopulmonary bypass.The patient gained reasonable but not good contractility of the right heart.The patient's right heart continued to fail with progressively more hypotension.Medications and intracardiac massage were given.Right heart was never able to get into a functional state and the patient was pronounced dead.

• Brand Name: ONX LIFE TECHNOLOGIES, INC.
• 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 ; 7704193355
• MDR Report Key: 7864132
• MDR Text Key: 119826780
• Report Number: 1649833-2018-00148
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ONXAAP-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/16/2018
• Date Manufacturer Received: 08/16/2018
• 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: 44 YR