MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART VALVE MECHANICAL

Model Number ONXMC-25/33

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to initial report,"2 incidents of explantation due to thrombosis.One approx.12 months ago and one approx.18 months ago.(note: 'date of incident' field, above, is approx.Only) reported to rep during field visit with surgeon in india (b)(6) 2017."it was reported that one patient died after having experienced symptoms for over one week.The other patient had valve explanted and replaced by other mechanical valve (not on-x)." multiple attempts have been made for additional information.However, all attempts at correspondence have gone unmet.Note it is unclear based on the initial information which patients experienced explant, thrombosis or death.This investigation will be relegated to the thrombosis events.

Manufacturer Narrative

A review of the available information was performed.An anecdotal report from the surgeon to the sales representative on (b)(6) 2017 reported one on-x mitral valve replacement (mvr) recipient experienced symptoms of thrombosis about a year ago and a second mvr patient about 18 months ago.Both patients underwent explantation of their mitral on-x valves.Neither valve was identified by serial number, so model(s) and size(s) could not be verified.One of these patients died after over a week of symptoms and the other received a new (non-on-x) valve replacement after explantation of the original on-x valve.It was not indicated which patient lived and which did not.The status of anticoagulation therapy is completely unknown in both cases.The valves were not available for examination.We do not know the genesis of either thrombus.There is no medical record to consult as this is only word-of-mouth.We do not know the actual cause of death of the one patient nor how long he/she survived post-explantation.With the paucity of specificity, we can only evaluate these events in broad statistical terms.While thrombosis is a recognized potential complication associated with prosthetic mitral valve replacement, as are explantation and death [instructions for use], its occurrence is relatively rare.Objective performance criteria report an historical thrombosis incidence of 0.8% per valve-year for all rigid prosthetic valves (b)(4).There is not enough specific, nor objective, information available to establish any cause for either the thromboses or the reported death; so we do not know what, if any, relationship the valves may or may not have had with the events reported.A definitive root cause for this event is not possible and based on the limited available information.No further action necessary.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to initial report,"2 incidents of explantation due to thrombosis.One approx.12 months ago and one approx.18 months ago.(note: 'date of incident' field, above, is approx.Only) reported to rep during field visit with surgeon in (b)(6) 2017."it was reported that one patient died after having experienced symptoms for over one week.The other patient had valve explanted and replaced by other mechanical valve (not on-x)." multiple attempts have been made for additional information.However, all attempts at correspondence have gone unmet.Note it is unclear based on the initial information which patients experienced explant, thrombosis or death.This investigation will be relegated to the thrombosis events.

• Brand Name: ONX MITRAL CONFORM 25/33
• 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: 6877395
• MDR Text Key: 86703531
• Report Number: 1649833-2017-00067
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONXMC-25/33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/25/2017
• Date Manufacturer Received: 08/25/2017
• 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): Other; Required Intervention