Medical Device Caused Brain Damage, Lawsuit Alleges

The device may have been part of a previous recall by the FDA.

A Washington state man is suing Penumbra, claiming their Coil 400 medical device used to treat his aneurysm malfunctioned and caused him to suffer brain damage, according to the Associated Press.

According to the article, the lawsuit claims, "the doctor placed 90 percent of the coil into the aneurysm, but the last 10 percent got stuck in the intracranial artery."

The doctor was not able to remove the coil, which detached prematurely and remained, along with a stent, in the man's brain, causing him to suffer a stroke, according to the article.

In 2011, about 267 lots of Penumbra Coil 400 products were involved in a Class I recall by the FDA, who said, according to the article, "that it found that the pull wire on the delivery tool could slip out of place and allow premature detachment of the Coil 400."

A year later in 2012, the agency gave clearance to Penumbra to market the device again. The device in question was manufactured on Aug. 11, 2011 and had an expiration date of Aug. 31, 2013, according to the lawsuit.

The pateint's lawyer told the Associated Press, "they are trying to determine whether the device was one of the recalled coils, or if the new ones have the same problem."

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