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Devices’ Coating Detaches, Fragments Cause Clots; Worldwide Recall


On October 14, 2016, Medtronic recalled certain lots of five of its products: (1) Pipeline embolization device, (2) Alligator retrieval device, (3) X-Celerator hydrophilic guidewire, (4) the stylet containing UltraFlow flow directed micro catheters, and (5) Marathon flow directed micro catheters. These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group.

 

These five products were recalled due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, depending on the size and quantity, could lead to a thromboembolic event. This is a formation in a blood vessel of a clot (thrombus) that breaks loose and is carried by the blood stream to plug another vessel. The clot may plug a vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg.

 

At the initiation of this recall, 84,278 units potentially affected by this recall had been distributed worldwide. The products were manufactured from July 2014 to September 2016.

 

The Pipeline embolization device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The first generation Pipeline embolization device is affected by this action due to the PTFE coated delivery wire, which is part of the disposable delivery system (the braid implant is not affected). The second-generation device, Pipeline Flex embolization device, is not affected by this recall.

 

The Alligator retrieval device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval.

 

The X-Celerator hydrophilic guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures.

 

The UltraFlow flow directed micro catheter is designed for the subselective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels.

 

The Marathon Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives, September 2016 Report: Stroke: Challenges, Risks, and Liability Issues

 

See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death 

 

 

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