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

Model Number UNKNOWN

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

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Tachycardia (2095)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

As reported in a post-market study, this patient experienced non-sustained vt (ventricular tachycardia) and af (atrial fibrillation) post procedure-resolved.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and (b)(6) 2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.

Manufacturer Narrative

A review was performed of the available information of the on-x prosthetic heart valve anatomic suture ring post-market study.The purpose of the study is to assess the rate of occurrence of permanent pacemaker implantation within 14 days of surgery with on-x prosthetic heart valve with anatomic sewing ring when used to replace diseased aortic valves in human subjects through the use of a retrospective registry.The protocol for this study is as follows: this study is multicenter and retrospective.All centers will follow a common protocol in which eligible patients will be entered into the registry after the 14th postoperative day.No procedures will be done and only retrospective data covering the preoperative, operative and the first 2 weeks postop will be collected.The valve safety primary endpoint is "occurrence of permanent pacemaker implantation within 14 days of surgery as a valve-related adverse event per the definitions of the american association for thoracic surgery/society of thoracic surgeons (aats/sts) guidelines." the valve safety secondary endpoint is "occurrence of other valve-related adverse events within 14 days of surgery per the definitions of the aats/sts guidelines." per the information available to us, this study began in 2013.The study was closed out 04/30/2018 and we are now becoming aware of the primary and secondary endpoints reported by all of the centers.For each event, the date of implant, date of event, and valve-identifying information is unknown.As reported in the post-market study, the patient, a (b)(6) year old male, is the recipient of an onxan or onxane model on-x valve in the aortic position.He was in sinus rhythm preoperatively and had 7 prior coronary stents.Postoperatively, he had non sustained ventricular tachycardia and atrial fibrillation, which were reported as resolved.A pacemaker was not implanted at this time.No other information is available following this diagnosis as the protocol limits adverse event reporting to 14 days postop.The aats/sts guidelines for reporting mortality and morbidity after cardiac interventions define the implantation of a permanent pacemaker or defibrillator within 14 days after surgery as a major valve related event.So, although this patient suffered arrhythmia postoperatively, he received neither a pacemaker nor defibrillator and so the event is not classified as a major valve related adverse event per the guidelines.Nevertheless, the instructions for use (ifu) lists cardiac arrhythmia as a potential complication following aortic valve replacement [ifu]; but as no pacer was implanted and we have no subsequent information, we do not know what, if any, relationship the arrhythmia has to the valve.

Event Description

As reported in a post-market study, this patient experienced non-sustained vt (ventricular tachycardia) & af (atrial fibrillation) post procedure-resolved.This study is multicenter and retrospective.The implants were standard mechanical valve implant procedures and data was collected post-operatively for events occurring within 14 days of surgery.The implant procedure was conducted sometime between 2013 and (b)(6)2018; the date of implant and valve-specific information is unknown.The reported event was collected retrospectively and not indicative of a real-time event occurring with the use of the on-x valve.

• Brand Name: ON-X PROSTHETIC HEART VALVE
• 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: 7540690
• MDR Text Key: 109139628
• Report Number: 1649833-2018-00041
• 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: company representative,study
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/30/2018
• Date Manufacturer Received: 04/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 178