MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC 23; HEART-VALVE, MECHANICAL

Model Number ONXAAP-23

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

Patient Problem Death (1802)

Event Date 07/31/2018

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 operative notes, patient died during surgery.

Manufacturer Narrative

A review of the available information was performed.The manufacturing records for the onxaap-23 sn [serial number] (b)(4) were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications.All lots passed functional testing and met release specifications.(b)(6) male patient implanted with onxaap-23 sn (b)(4) on (b)(6) 2018 indicated for ascending aortic dissection involving via emergent procedure finding "extensive aortic dissection all the way down to the aortic valve with severe ai on intraoperative tee prior to cardiopulmonary bypass [cpb]." the onxaap-23 was implanted and patient was weaned from cpb.The patient died same day intraoperatively.Op notes state "bleeding initially appeared to be ceasing and there was good cardiac rhythm and good indices" but then "bleeding became apparent somewhere posteriorly at the proximal anastomosis area.Multiple sutures were applied trying to stop the bleeding.This was unsuccessful.The patient developed bradycardia and a pea." it is possible that the death was due to the trauma of surgery, but there is no objective evidence to indicate what contribution, if any, the valve or the surgery had to the cause of death.Surgical death is a rare, but recognized potential complication associated with aortic valve replacement [instructions for use].As of 2016, the sts database indicated an operative mortality of 2% for aortic valve replacement procedures [sts].There is no evidence to indicate what, if any, relationship the valve had to the death of the patient.No further action is warranted at this time.

Event Description

According to the operative notes, patient died during surgery.

• Brand Name: ON-X ASCENDING AORTIC 23
• 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., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 7852116
• MDR Text Key: 119411157
• Report Number: 1649833-2018-00146
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: ONXAAP-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/15/2018
• Date Manufacturer Received: 08/15/2018
• 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: 60 YR