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

Model Number ONXA UNK

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

Patient Problems Endocarditis (1834); Transient Ischemic Attack (2109)

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 received via email on 03-sept-2020 from cryolife donation support, "a call just came in through our switchboard from an on-x recipient.He reports that he was diagnosed with an infection of his valve, which caused multiple subsequent strokes.He would like to speak with someone and obtain some information.He can be reached at +(b)(6)." additional information from the director on-x heart valve technologies, relayed per his phone conversation with the on-x recipient the following "pt experienced tia or rind events in (b)(6) 2019.(b)(6) 2020 the patient describes diagnosis of "infection of my valve" which caused multiple subsequent "strokes".Subjectively, in our conversation today i asked the patient how he was doing and he said "good".The patient had no audible residual verbal deficits and clearly explained his current status to me during the course of our call.Unless this patient has residual physical deficits, the true diagnosis may be either tia or rind versus "stroke".Patient described his endocarditis [stenotrophomonas rhizophila bacteremia] as a "bacterial infection caused by a type of bacteria usually found in plants".Patient wanted to know if the on-x valve could be infected by endocarditis.I discussed with him that the carbon components (carbon assembly) could not be impacted by the bacteria, but that the sewing ring and suture material from implantation could sometimes become involved due to infection effect on endothelial cell layers covering these.The patient stated that his physicians told him that the on-x valve was working well, but if the antibiotic course did not clear up the infection then the valve may have to be removed to treat the endocarditis of the surrounding tissue.Patient asked about endocarditis rate with on-x valves.I provided him with the fda approval study rate of 0.5%/pt year (explained in layman's terms) which was 2 cases over 3 years of study implants (stating that endocarditis is thankfully quite rare).I also explained to the patient that endocarditis can originate from various sources and in fact that is why pre-treatment with antibiotics prior to dental appointments and other lesser invasive procedures is recommended for all valve patients.I further explained bacterial and fungal stasis testing that valve manufacturers perform during sterility testing and validation, done for every valve.In follow-up i emailed this patient to create a simpler form of communication.He wanted to send me the name of the bacteria that was causing his endocarditis.In my email i requested that he send me a copy of the lab report and any medical notes that he wanted to share.Assessment: subjectively, again, the patient seemed quite satisfied with our conversation and expressed thanks to me/us for the lengthy call.He is now at home on his 6 week antibiotic [levofloxacin 500mg] course, and did not express any current limitations, although this was not specifically discussed during our call.".

Manufacturer Narrative

The manufacturing records were not reviewed as a serial number was not provided.A query of the device tracking database did not produce an implant registration card associated with a serial number either.A clinical associate and the medical director performed a review of the available information.A patient called cryolife claiming to have an on-x aortic valve and asking about endocarditis.The valve was not identified so it is not confirmed that the patient has an on-x valve.The patient described multiple occurrences of cerebrovascular accidents (cvas) and transient ischemic attacks (tias) and was told by his doctors that he had infective endocarditis.Cultures were positive for stenotrophomonas rhizophila bacteremia.A course of antibiotics was prescribed (currently in progress) and follow-up exams scheduled which are still pending as of information provided for this report.Echocardiograms, ct head, ct angiogram, mri, and pet scans confirm both small ischemic infarctions in the brain (age indeterminate) and possible infection on the ¿metallic¿ valve.The echoes indicated normal ejection fraction of the valve.The patient further disclosed that his physicians told him that his valve is working well, but the endocarditis could secondarily affect his valve so that it would need to be replaced.The patient also has an iron deficiency and a thyroid nodule.This is a case of probable endocarditis on the prosthetic valve, presently being treated medically but with the potential for replacement.However, if this is an on-x valve, the source of the infection is not likely to be from the valve itself which undergoes a validated sterilization process during manufacturing.The instructions for use [ifu] for on-x valve acknowledge endocarditis as a potential complication.Endocarditis shows an historical rate of occurrence of 1.2% per valve-year in rigid heart valves [iso 5840:2005 (e)].This is a case of probable endocarditis of unknown origin.If this is an on-x valve, there is no evidence that the valve itself failed to perform as designed.The instructions for use (ifu) provide instruction about the potential adverse events associated with the use of prosthetic heart valves which may lead to explantation and re-operation.The on-x heart valve risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product¿s labeling and ifu.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.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.

• 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., bldg. b; austin TX 78752
• MDR Report Key: 10515734
• MDR Text Key: 213067349
• Report Number: 1649833-2020-00035
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ONXA UNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening