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

Model Number ONX UNK

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

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 the initial report, "we were told that more than two years ago, there was some clotting on an on-x valve and the patient had to then see the cardiologist to be thrombolysed.When we pressed for more information, the only things we could find out were that they do not recommend patients to take aspirin and the also do not believe the inr can be maintained at 1.5-2.They tell the patients and cardiologists 2.5 to 3.As was not being made and it was so long ago, no other information could be provided." patient impact reported as "the patient had to see the cardiologist mr (b)(6) to be thrombolysed.".

Manufacturer Narrative

Multiples attempts were made to obtain the following clarifying information without success: specific product code and serial number, date of implant, date of event/death, date of intervention, historic record of inr preceding and at time of event, pertinent patient comorbidities.The manufacturing records for the on-x aortic valve were not performed as the product code, serial number, and definitive date of implant were unavailable.As such, the system could not be queried for potential serial numbers shipped to the hospital.The field report refers to an incidence two years ago of "some clotting on an on-x valve," presumed to be in the aortic position.The validity of this case as on-x cannot be established as no valve or implanting or patient information was provided.The report further states that this (b)(4) site does not prescribe aspirin to its valve recipients and promotes an inr range of 2.5-3.0.The lack of aspirin and the inr range prescribed are contrary to the recommendations for the on-x aortic heart valve prosthesis (75-100mg asa daily and inr maintained at 1.5 - 2.0) in the instructions for use (ifu).The thrombus was treated with thrombolysis (presumably medication).Thrombosis, or "clotting," is a rare, but recognized risk for recipients of mechanical heart valve prostheses.The historical rate of occurrence for rigid valves is (b)(4) per valve year [iso 5840:2005].The off-recommended anticoagulation therapy prescribed by this site makes conclusions mixed.Taking no aspirin would increase the risk of thrombus formation, while a higher than recommended inr would tend to decrease it.The risk of bleeding from anticoagulation is conversely related to the risk of thrombus.We have only an anecdote of clotting on an on-x valve.There is no inr history record and no assessment of the patient's condition at the time of the event.No objective evidence was made available to ascertain the histology, size, or origin of the clot or clots nor the detection method used to make the diagnosis.The evidence is insufficient to determine what, if any, relationship the diagnosis of clotting on the valve has to the valve itself.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the initial report, "we were told that more than two years ago, there was some clotting on an on-x valve and the patient had to then see the cardiologist to be thombolysed.When we pressed for more information, the only things we could find out were that they do not recommend patients to take asprin and the also do not believe the inr can be maintained at 1.5-2.They tell the patients and cardiologists 2.5 to 3.As was not being made and it was so long ago, no other information could be provided." patient impact reported as "the patient had to see the cardiologist, (b)(6) to be thrombolysed.

• Brand Name: ON-X AORTIC VALVE UNKNOWN CONFIGURATION
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ON-X LIFE TECHNOLOGIES, INC.; 1300 e. anderson ln; 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
• MDR Report Key: 6178090
• MDR Text Key: 62466922
• Report Number: 1649833-2016-00080
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ONX UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/18/2016
• Date Manufacturer Received: 11/18/2016
• 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): Hospitalization; Other