Dive Brief:
- Boston Scientific is removing certain catheters used for a stroke prevention treatment over the risk that the device tip can separate during a procedure.
- As of July 9, Boston Scientific has reported one injury related to the problem, according to an early alert posted by the Food and Drug Administration on Friday. Boston Scientific spokesperson Chanel Hastings wrote in an email to MedTech Dive that the company is aware of one reported stroke associated with the problem and the need for additional interventions in some cases.
- Boston Scientific sent a letter to customers earlier this month instructing them to stop using or distributing the affected devices, which are under the Enroute Transcarotid Neuroprotection System brand.
Dive Insight:
The Enroute devices are used during stenting procedures to treat carotid artery disease and prevent stroke. While the stent is placed, the device reverses blood flow to protect the brain. The system is intended to reduce the rate of complications experienced with traditional open surgery.
Boston Scientific acquired Enroute with its purchase of Silk Road Medical in 2024. The company has pulled certain devices due to risks that the arterial sheath tip may separate, or partially separate, during use. If that happens, surgical retrieval of the tip may be needed.
Complications can include embolism, stroke, a transient ischemic attack, re-narrowing of the blood vessel or blood clots, according to the FDA.
Boston Scientific has started an investigation into manufacturing variability associated with the identified lots, Hastings wrote. Devices outside of the affected subset are not part of the product removal.
