KBA monitors FDA recalls to identify potential claims against medical device companies. Medical device company, Styker, makes a product called, Trevo XP ProVue Retrievers. Doctors use this device to restore blood flow or to remove blood clots when a patient is experiencing an ischemic stroke. The company is recalling more than 1200 devices because the core wire may break or separate when the device is being retracted. “The US FDA gave its highest risk classification to a recall by Stryker of a medical device that’s used on stroke patients.”
The FDA cleared the medical device on June 25, 2019. The indications for use follow:
As Styker described in its 510(k) submission to the FDA, “[t]he Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the
distal end.” The device labeling (directions for use (“DFU”)) includes several warnings. The company has access to a registry to track product use. The Trevo Retriever Registry, is a multicenter, international data collection study that collects “real-world data on the Trevo XP ProVue retriever.” After releasing the product to the market, Stryker observed an increase in complaints.
Stryker initiated a recall on September 21, 2020. FDA created a Class I recall on October 21, 2020. “A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA).” A Class I device recall involves “[a] situation where there is a reasonable chance that a product will cause serious health problems or death.”
Stryker’s Trevo XP ProVue Retrievrs recall is due to an “[i]ncrease in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.” Put simply, a piece can break of or separate during and get stuck in the patient’s blood vessel. That could This could cause serious injuries. Stryker sent a letter out about the recall.
The FDA Class I recall involves the following products: Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002.
|Action||On 09/21/2020, Urgent Medical Device Voluntary Recall – Removal notices were distributed to customers via courier. Risk Management/ Recall Coordinators/ Inventory Managers were asked to do the following:1. Immediately check your internal inventory for affected devices.
2. Segregate the affected units in a secure location for return to recalling firm.
3. Circulate this Recall-Removal notice internally to all interested/affected parties.
4. Maintain awareness of this communication internally until all required actions have been completed within your facility.
5. Inform firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.
6. Inform recalling firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com)
7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 8. Email the completed form to NVCustomerCare@Stryker.com 9. Product Return Information will be provided to you by your designated Territory Manager or Sales Representative
If you have had issues after an acute ischemic stroke and had a neurovasculature produced, including removal of thrombus, speak with your doctor. KBA cannot provide medical advice, and recommends no action related to use of the product. Speak with your physician and see if you had Trevo Retrievers and if that could be causing problems. If so, you may have legal rights. There may be medical device litigation involving product liability claims. For more information, Contact KBA today to discuss.
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