MAUDE Adverse Event Report: CRYOLIFE,INC/ON-X LIFE TECHNOLOGIES AORTIC HEART VALVE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Stroke/CVA (1770); Stroke/CVA (1770); Embolism (1829); Embolism (1829); Fall (1848); Fall (1848); Ischemia (1942); Ischemia (1942); Paralysis (1997); Paralysis (1997); Seizures (2063)

Event Date 08/19/2017

Event Type  Injury  

Event Description

I experienced an ischemic stroke on (b)(6) 2017 caused by the mechanical on-x prosthetic heart valve in aortic position that was implanted on (b)(6) 2016.The stroke happened while i was mountain biking in a remote area and my right leg and right arm were paralyzed - causing me to fall and to be immobilized for several hours.This happened in a remote area around (b)(6).I still had to go for another 10 miles.At times when the paralysis subsided and i was barely able to move my leg and arm for periods of time.I tried to push my bike and struggled to get back to the car.I had multiple re-occurrences of the paralysis and it took me hours to get back to meet up with my wife.I was confused, not able to communicate with her and was barely able to mount the bike on the car rack and to remove my biking shoes.My wife drive us back home (2 hr car ride).I did not understand what was happening to me and was confused, had apathy and was exhausted.At home my son who is a medical student immediately identified the stroke symptoms and called 911.I was rushed to the emergency room at (b)(6), admitted to the stroke and underwent a comprehensive examination for acute ischemic stroke.It was determined that i had a stroke that affected the left middle cerebral artery (lmca) which controls motor function and language.It was determined that the stroke was caused by an embolism (blood clot).The cause for the left middle cerebral artery ischemic stroke was determined to be caused by the mechanical valve.The inr at admission was at 2.03 per the recommendation of the valve mfr on-x life technologies (cryolife).Mrs.(b)(6), md, (b)(6) determined that the anticoagulation range has to be increased to an inr of 2.5-3.0.However, on-x advertises and educates the cardiologists and pts about their 2015 fda approval where it advises a target inr range of 1.5-2.0.I received such communication again ("important anticoagulation info for on-x aortic valve recipients") early january 2018.Based on my ischemic stroke - caused by a too low and false recommended inr this claim and communication is wrong, dangerous and careless.I have also learned about other pts with similar adverse experiences with the on-x valve; a 23 mm heart valve.

Event Description

Additional info received from reporter on (b)(6) 2019 for mw5075264.I experienced on (b)(6) 2017 an ischemic stroke with an inr of 2.03 and filed on (b)(6) 2018 a voluntary medwatch report (mdr report key (b)(4)).Thank you for processing and entering this report into the maude adverse event report database under the company name cryolife inc./on-x life technologies.On (b)(6) 2018 i experienced a seizure that has been diagnosed to be caused by the brain injury from the stroke in (b)(6) 2017.This was very devastating for me and i am not sure how my future treatment will look like.I want to take this very troubling event to ask for a follow-up - especially by the manufacturer of this artificial heart valve.On ¿ x life technologies is still advertising the low inr range of 1.5-2.0 and judging from my personal bad experience ¿ is putting other patients at risk.There are also other entries in the maude database reporting stroke events with the on -x valve and i am also in contact with other patients with this valve that experienced a stroke and now also had to increase the lower limit for the inr to 2.5.These patients have not filed a voluntary medwatch report as far as i know.On x- life technologies is claiming ¿inr can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bi-leaflet mechanical prosthesis¿.I would like to request the food and drug administration to question the basis for this valve ¿ especially since other, very similar valves operate with a lower recommended limit for the inr of 2-2.5.Information accessible to me where the manufacturer determined the inr range for this valve was based on low number of patients [1].I also question how adverse events such as that i encountered are being considered and used to evaluate the inr range and if they are properly evaluated and analyzed by the manufacturer.I look forward to your follow-up and response- thank you for your support.

• Brand Name: AORTIC HEART VALVE
• Type of Device: AORTIC HEART VALVE
• Manufacturer (Section D): CRYOLIFE,INC/ON-X LIFE TECHNOLOGIES
• MDR Report Key: 7273295
• MDR Text Key: 100313305
• Report Number: MW5075264
• Device Sequence Number: 0
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/13/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Weight: 79