MAUDE Adverse Event Report: ARTIVION (FORMERLY CRYOLIFE) ON-X HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 25 MM AORTIC

Device Problem Noise, Audible (3273)

Patient Problem Discomfort (2330)

Event Date 11/17/2022

Event Type  Injury  

Event Description

As a congenital heart defect patient, my diseased bicuspid aortic valve was recommended for replacement.In 2017, i had a valve repaired in (b)(6).This past (b)(6), the valve was recommended to be replaced with an on-x 25 mm aortic replacement valve via open-heart surgery.The device manufacturer is artivion.A problem that is not reported by the device manufacturer and congenital heart defect groups is that sound that the valve makes.With a frequency decomposition, the main frequency heard is 13 khz and ranges from 50 - 65 db.Not only is the sound heard through air, i hear the sound as a vibration.Using a biofeedback loop, i was able to estimate the sound intensity of the valve.As a reference, most inside speaking voices happen around 60 db.Since the valve's sound is so loud, i hear every beat all the time.Most with normal hearing can also hear the valve if they are near me.The problem that needs pointed out is the psychological impact.Listening to the valve's sound all the time is a problem that needs addressed.To put this as an economic problem, i was a high performing research & development engineer for an american icon.Now, i can barely read multiple sentences and comprehend because the valve's sound is so distracting.Frankly, the device manufacturer needs to do better.Decreasing someone's quality of life so severely by this sound is not acceptable.The fda needs to review its guidance to the device manufacturer, artivion, and continue to advise if the valve should be allowed in the us.This problem is with the on-x heart valve.

• Brand Name: ON-X HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ARTIVION (FORMERLY CRYOLIFE)
• MDR Report Key: 16565324
• MDR Text Key: 311567991
• Report Number: MW5115790
• Device Sequence Number: 1
• 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
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 25 MM AORTIC
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLERGY MEDICATION AS NEEDED FOR SEASONAL ALLERGIES; NAPROXEN; WARFARIN TO THIN BLOOD REQUIRED BY IMPLANTED VALVE.
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White