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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL/ABBOTT VASCULAR MECHANICAL AORTIC VALVE
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ST. JUDE MEDICAL/ABBOTT VASCULAR MECHANICAL AORTIC VALVE Back to Search Results
Model Number 25AGFN-756
Device Problems Leak/Splash (1354); Defective Device (2588); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)
Patient Problems Cardiomyopathy (1764); Cardiomyopathy (1764); Myocardial Infarction (1969); Myocardial Infarction (1969); Ventricular Fibrillation (2130)
Event Date 04/24/2017
Event Type  Injury  
Event Description
On (b)(6) 2011, i had a st.Jude aortic mechanical valve installed.Apparently it has been leaking.In (b)(6) 2016 i started getting sick and my dr.Suggested to see cardiologist.Two cardiologists and my surgeon have all three recently confirmed that the mechanical valve is malfunctioning, defective and leaking.The surgeon wants to replace the mechanical valve with a pig-cow tissue valve.The leakage caused enlargement of left ventricle (cardiomyopathy) which lead to a heart attack in (b)(6) 2016 which lead to a hospital stay.The leakage caused by the defective valve caused hcc ventricular tachycardia.This lead to the need of an icd heart pacer to keep me alive.I have contacted st.Jude who is now partnered with abbott about their defective mechanical heart valve.My surgeon is dr.(b)(6) and he can verify the above.The mechanical valves are made of titanium and they do not bond well with human tissue.Many leak afterwards on the inside and outside of the mechanical valve.The pig-cow tissue valve from what i researched has a much better chance of bonding to the heart without leakage.I feel the mechanical valve is defective and it has disabled me to the point where i can no longer perform work.As a result i now have cardiomyopathy, ejection fraction of 25 percent and i'm only (b)(6).I have contacted st.Jude/abbott and i am awaiting their reply.(b)(6).I have all my medical records to download and send if needed.Thanks for any help given.(b)(6).
 
Event Description
Add'l info received from reporter for report #mw5070117 on 02/09/2018.Early (b)(6) 2017 i filed a report with medwatch about a defective, leaking, malfunctioning mechanical valve installed by st jude in (b)(6) 2017.I filed charges against st jude in (b)(6) 2017 and we are currently filed in (b)(6) court to possible resolve the error.December 22, 2017 (b)(6) hospital evaluated a 60% leak of the mechanical aortic valve and replaced the defective valve with a tissue valve.Before the surgery, dr (b)(6) who was the surgeon at (b)(6) hospital requested the movie sonar scan of the defective mechanical valve that was performed by dr (b)(6) (cardiologist) (b)(6) 2017 at (b)(6).This request was by dr (b)(6) in (b)(6) 2017.When i contacted (b)(6) about a copy of the movie sonar scan that dr (b)(6) requested (b)(6) replied that the movie sonar scan was never performed at their facility and that it was performed at the hospital.The hospital in (b)(6) claims that the movie sonar scan was never performed at their hospital and that it was performed at (b)(6).The copy of the movie sonar cd was vital to dr (b)(6) as he was determining replacement of the mechanical valve to tissue valve.Around (b)(6) 2017, i sent a demand letter to st jude the mfr of the defective mechanical heart valve and also demand letter to the top three executives including (b)(6).The demand letters were through certified mail in which signatures were needed to be received.The demand letter was a charge for the damages of the defective st jude valve and the add'l damage that the defective valve caused to other parts of my heart, legs, and feet.Dr (b)(6) arranged (b)(6) 2017 to perform a movie sonar scan of the damaged st jude valve to get a closer look at the valve.He requested that i arrive the day of the call and that i arrive after working hours at (b)(6) health center.He said he would perform his movie sonar scan after work and that i would not be charged on (b)(6) insurance.Arriving their 2 of the staff were extremely friendly and no paper work was used, only the movie sonar scan performed.(b)(6) had no cause to perform an immediate movie sonar scan; however, when st jude received my letter of demands that it is when st.Jude or possible one of the 3 executives that received certified mail signature requirements called (b)(6) (b)(6) 2017 to perform a movie sonar scan of the defective aortic mechanical st jude heart valve to determine the extent of defect and injury.The medical scan was fraudulent because it was performed for only st judes info and not available for my medical records which were required in the fall of 2017 when the st jude valve had to be replaced (b)(6) 2017.My complaint and filing is that st jude or one of their top 3 executives committed medical fraud in ordering a movie sonar with the intention of being medically documented in order for st jude to determine if they had a bad product or not because the valve was defective and had a minor leak for a few years and major leak last year 2017 which is documented by surgeon dr (b)(6).The leaking of the valve caused an enlarged left ventricle and moderate enlarged left atrium resulting in cardiomyopathy and severe fibrillation of the ventricle.Add'l to the surgery, i will require a catheter ablation on the left ventricle at (b)(6) hospital.I am requesting that an investigation be opened to determine by the fda and or medical board of the medical fraud that was performed (b)(6) 2017 commitment of medical fraud.Since then we did file charges in (b)(6) court with civil file (b)(4).Also i request a copy of this medical complaint by mail or email.For the damage i was seeking as the doctors evaluated that the valve would need replaced.The mechanical valve was supposed to last around 20 years and only lasted 4 to 6 years, also because it.
 
Event Description
On (b)(6) 2011, i had a st.Jude aortic mechanical valve installed.Apparently it has been leaking.In (b)(6) 2016 i started getting sick and my dr.Suggested to see cardiologist.Two cardiologists and my surgeon have all three recently confirmed that the mechanical valve is malfunctioning, defective and leaking.The surgeon wants to replace the mechanical valve with a pig-cow tissue valve.The leakage caused enlargement of left ventricle (cardiomyopathy) which lead to a heart attack in (b)(6) 2016 which lead to a hospital stay.The leakage caused by the defective valve caused hcc ventricular tachycardia.This lead to the need of an icd heart pacer to keep me alive.I have contacted st.Jude who is now partnered with abbott about their defective mechanical heart valve.My surgeon is dr.(b)(6) and he can verify the above.The mechanical valves are made of titanium and they do not bond well with human tissue.Many leak afterwards on the inside and outside of the mechanical valve.The pig-cow tissue valve from what i researched has a much better chance of bonding to the heart without leakage.I feel the mechanical valve is defective and it has disabled me to the point where i can no longer perform work.As a result i now have cardiomyopathy, ejection fraction of 25 percent and i'm only (b)(6).I have contacted st.Jude/abbott and i am awaiting their reply.(b)(6).I have all my medical records to download and send if needed.Thanks for any help given.(b)(6).
 
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Brand Name
MECHANICAL AORTIC VALVE
Type of Device
MECHANICAL AORTIC VALVE
Manufacturer (Section D)
ST. JUDE MEDICAL/ABBOTT VASCULAR
MDR Report Key6604566
MDR Text Key76526112
Report NumberMW5070117
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 02/08/2018
2 Devices were Involved in the Event: 1   2  
2 Patient was Involved in the Event
Date FDA Received05/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number25AGFN-756
Device Catalogue Number25AGFN-756
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age53 YR
Patient Weight82
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