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Lawsuit Claims Medical Device Caused Brain Damage

A Washington man is filing a suit against a California company for making an implant that he said malfunctioned.

Qmed Staff

The software developer is suing Penumbra Inc. because he says that the company's Penumbra Coil 400 device caused brain damage. After suffering an aneurysm in 2013, Dennis Montgomery was treated with the device. When the device was placed into the aneurysm, 10% remained stuck in the intracranial artery. 

According to Montgomery's attorney, Peter Mullenix, the device detached prematurely, leaving fragments from the device lodged in his brain, which later caused him to have a stroke. Mullenix said if the device were designed properly, a surgeon should have been able to extract the device intact and replace it in the brain. 

"When a coil system malfunctions and leaves the coil in the middle of the artery instead of safely inside the aneurysm, the coil starts throwing clots, which can turn into strokes," Mullenix told the AP. "That's what happened to Dennis."

The suit specifically cites the maker of the device, Penumbra, as well as two of its sales reps who were present during the surgery on Montgomery. Also, the suit also lists Overlake Hospital Medical Center in King County Superior Court.

Montgomery is seeking reimbursement for medical and economic costs as well as damages against the parties involved in the case.

Penumbra filed a motion to have the case dismissed.

In 2011, a recall of the Penumbra Coil 400 was given Class I status. According to the FDA description: "The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to migrate unintentionally. This detachment problem can lead to serious injury including blood clots and stroke." The FDA recall notice was posted in April of 2011.

According to the lawsuit, the device that was implanted in Montgomery was made on August 11, 2011 and had an expiration date of August 31, 2013, the suit said.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016. 

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