MAUDE Adverse Event Report: AGA MEDICAL AMPLATZER OCCLUDER

Model Number 9-ASD-MF-025

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Chest Pain (1776); Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Paralysis (1997); Rash (2033); Loss of Vision (2139); Visual Disturbances (2140); Arthralgia (2355); Collapse (2416)

Event Type  Injury  

Event Description

In (b)(6) 2013 was implanted with an amplatzer pfo closure device made of nitinol.Immediately following surgery was having severe migraine, visual disturbances, aura, nausea, chest pain, body pain.Told this to the physician dr.(b)(6) and was ignored and invalidated.Three weeks post surgery i collapsed and was found by neighbour.Horrific stroke like me migraine, left side paralysis, expressive aphasia, loss of bowels and bladder, extreme head pain, rashes, joint and muscle pain, inability to be in light.Loss of memory, could not read, watch tv, drive or work.Lost vision, scotoma, horrific nummular pain, uncountable symptoms.Was brought to er by ambulance and again invalidated.Put on morphine drip and left to suffer.Was released into care of my old boss while in almost vegetative state.Rehospitalized 4 times.Then was completely bed ridden for 2 years.A different cardiologist hinted to me to see what device was made out of.Dr.(b)(6) at (b)(6) saw me and said to remove the device - it was killing me.Dr.(b)(6) who put the device in could have removed it but ignored me and left me to suffer unbelievably.By this time heart had fibrosis around this hideous device and required open heart surgery to remove.Nitinol is a toxic heavy metal and many people can also be allergic to it.It ruined my immune system, i lost a 28 year long career in the sciences, all my income, and my health.I have suffered beyond any reasonable measure and i see thru searching the narrative in fda records that tens of thousands suffer too due to your approval of these devices.This includes numerous nitinol devices such as cardio seal, amplatzer, essure, stents, catheters.This list goes on and on but you do nothing! these devices and nitinol material needs to stop being used now.These are not acceptable risks.This is willful blindness on the part of the government, device makers, doctors, and the fda.Give me a break! do something about this!.

• Brand Name: AMPLATZER OCCLUDER
• Type of Device: OCCLUDER
• Manufacturer (Section D): AGA MEDICAL
• MDR Report Key: 7199809
• MDR Text Key: 97721617
• Report Number: MW5074606
• Device Sequence Number: 1
• Product Code: MAE
• 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: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-025
• Device Lot Number: 3963873
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Weight: 50