Deans' stroke musings: FDA issues warning about Covidien brain device that has killed nine

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, July 3, 2012

FDA issues warning about Covidien brain device that has killed nine - Onyx glue

Be careful out there. This is one of the options for handling aneurysms, coiling, surgery and mesh being the others. Ask your doctor on the risks for each. The earlier positive report here
http://medcitynews.com/2012/07/fda-issues-warning-about-covidien-brain-device-that-has-killed-nine/
The Food and Drug Administration issued a warning to physicians and patientsMonday about the Onyx Liquid Embolic System where the catheter used to deliver the liquid can get stuck inside the patient’s brain.
The product – formerly made by Minnesota-based ev3 – is now part of Covidien which acquired the company in for $2.6 billion in 2010.
The Onyx Liquid Embolic System is intended for patients who have abnormally-formed blood vessels in the brain. These are known asbrain arteriovenous malformations or brain AVMs. The Onyx liquid, delivered via a catheter, solidifies when it touches blood, thereby preventing blood flow to the AVMs. The product is used before a physician can surgically remove the malformed blood vessels.

But, FDA noted that there have been more than 100 reported cases where the catheter was entrapped or stuck in the Onyx implanted material. In some of the cases the catheter could later be removed but in 54 of these, they could not.The FDA advisory also noted that in the clinical data that ev3 presented before the approval, did acknowedge the chance for the so-called catheter entrapment and that the catheter could be removed albeit with some difficulty. However, the company found no evidence that the catheters could not be removed at all.
The marked discrepancy calls for a change in product labeling, FDA said.
Covidien spokesman David Young said that the company is cooperating with the FDA to correct the problem of labeling immediately. However, he declined to say how many patients have undergone the procedure, which was approved in 2005.