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 Congestive Heart Failure (1783); Death (1802)

Event Type  Death  

Manufacturer Narrative

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 04/30/2018; 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.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

As reported in (b)(6), this patient experienced congestive heart failure leading to death.Patient's disease etiology is calcific with atrial fibrillation.Patient had prior mechanical mvr [mitral valve regurgitation] with subsequent development of a mvr paravalvular leak.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 04/30/2018; 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 of the available information of (b)(6) was performed.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, (b)(6) male, calcific disease etiology, nyha iii, mixed lesions, with a history of prior mechanical mitral valve regurgitation [mvr] with subsequent development of a mvr para-valvular leak.By protocol, they are the recipient of an onxan or onxane model on-x valve in the aortic position.Postoperatively, the patient developed congestive heart failure [chf] and died.Crfs [case report form] indicated that the chf was not valve related.No other information is available following these observations as the protocol limits adverse event reporting to 14 days postop.Non valve related chf would likely indicate an association with either cardiac muscle failure or conduction failure but no definitive information is available.There is no indication that the on-x valve contributed to the event.Although relatively rare, death is a recognized potential adverse event associated with heart valve replacement [instructions for use].Definitive root cause for the reported event is unknown, not enough information to indicate a cause for the chf.However, crf information states the chf is not valve related.No further action is required at this time.

Event Description

As reported in (b)(6), this patient experienced congestive heart failure leading to death.Patient's disease etiology is calcific with atrial fibrillation.Patient had prior mechanical mvr [mitral valve regurgitation] with subsequent development of a mvr paravalvular leak.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 04/30/2018; 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; 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: 7550422
• MDR Text Key: 109447329
• Report Number: 1649833-2018-00063
• 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: study
• Reporter Occupation: Other
• 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: 05/29/2018
• 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
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/30/2018
• Date Manufacturer Received: 04/30/2018
• 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: 75 YR
• Patient Weight: 72