Medtronic StrataMR Valves and Shunts Recalled Due to Adverse EventsMar 22, 2017
Medtronic StrataMR Neurological Devices Recalled
Medtronic is recalling its StrataMR adjustable valves and shunts this month, the company said in an Urgent Field Safety Notice. The voluntary recall, which affects all unused units, is being issued due to problems with flow resistance; this can cause under drainage of cerebrospinal fluid. The Medtronic StrataMR valves and shunts are neurological devices used to treat hydrocephalus, a condition where there is a buildup of cerebrospinal fluid (CSF) within the ventricles of the brain; this condition was once called "water on the brain."
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Medtronic said the StrataMR valves and shunts are being recalled because patients may experience under drainage of CSF when the valve mechanism is changed to a position that causes higher than expected flow resistance. According to the recall notice, this can lead to adverse events such as headaches, nausea, vomiting, and lethargy. If this issue is not corrected, it could lead to coma or death.
According to the recall alert, there may be a higher than intended flow resistance if the MRI resistance key is placed on top of one of the MRI resistance walls instead of one of the pressure setting walls. Medtronic states that this can only happen when the valve is being adjusted, and subsequently placed into a position that causes a higher than intended flow resistance.
"Our investigation determined an increase in the occurrence rate of StrataMR™ complaints, related to incorrect flow or level change, in the month of January 2017," the company noted in the recall alert. "Due to this increase, the complaint rate is 1.45% of total units distributed since November of 2015; 1.1% of total units distributed resulted in revision surgeries."
Medtronic has not received any reports of death related to the recall so far.
Customers affected by the recall are advised to identify and quarantine the affected products. These devices should be returned to Medtronic, the recall notice states.
Medtronic issued another recall for neurovascular devices in October 2016. The voluntary recall affected certain lots of Medtronic's Pipeline embolization device, Alligator retrieval device and X-Celerator hydrophilic guidewire and stylet containing UltraFlow flow director micro catheters and Marathon flow directed micro catheters. The company said the recall may affect a total of 84,278 units manufactured since July 2014 to September 2016.
The devices were recalled because patients may experience a blood clot if the polytetrafluoroethylene coating separates from the delivery wire or stylets.
What is the StrataMR?
The Medtronic Strata MR valves and shunts are used to treat hydrocephalus, a condition where there is excess buildup of CSF. The brain and spinal cord are submerged in CSF, which helps cushion the central nervous system and prevent injury. CSF is produced by the ventricles, or deep cavities within the brain.
In patients with hydrocephalus, the excess buildup of CSF within the ventricles can put pressure on the brain, and damage brain tissue. This can lead to brain dysfunction.
StrataMR valves and shunts are designed to redirect CSF from the ventricles into the heart or peritoneal cavity. Doctors can adjust the flow rate of these neurological devices non-invasively by using magnetic adjustment tools. In May 2016, the FDA approved StrataMR valves and shunts for patients with hydrocephalus and CSF conditions.
According to Medtronic, the StrataMR valves and shunts are supposed to remain unaffected by changes in the external magnetic environment. Patients with these devices should be able to undergo a magnetic resonance imaging (MRI) scan up to 3.0 Tesla in accordance with the labeling, the company website states.
An MRI is a type of diagnostic imaging that uses magnetic fields and radiofrequency pulses to visualize different tissues and fluids; it is especially helpful for imaging the complex structure of the brain. Patients with hydrocephalus and other neurological conditions frequently need to undergo an MRI. Unlike other imaging methods, MRI does not use radiation.
Due to the presence of a strong magnetic field, patients and health care providers must be careful about any medical devices that enter the MR environment. Some devices are MR-safe, while others are not.
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