This article was found during a recent literature search of this device.Please note that patient specific details (demographics, medical history, and reason for intervention) are not available.The device is an unknown savvy balloon catheter and the catalog and lot numbers are not available.Kimiagar et al,.(2008).Carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years., imaj; 10: 121¿124.As reported by kimiagar et al,.(2008).Carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years., imaj ; 10: 121¿124; intraprocedural complications of a cerebrovascular accident (cva) occurred in two patients.The procedure was a carotid artery stenting that was performed with a low profile 4-20mm savvy balloon catheter, which was used for pre-dilatation after administration of 0.6 mg atropine, and then a stent was deployed from the internal to the common carotid.The device was not returned for analysis.Additionally, as the sterile lot number was not available, device history record (dhr) reviews could not be performed.Given the limited information provided, the reported event ¿cva¿ could not be confirmed and the exact root cause could not be determined.Cerebrovascular accident is a known potential risk associated with implanting a stent in a carotid artery.It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure.The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process).The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion.This act, inherent to the procedure may have contributed to the reported event.Additionally, usage of the product other than that indicated in the product's instructions for use (ifu) may involve additional risks not described in the labeling.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
|
As reported by kimiagar et al., (2008), carotid artery stenting in high risk patients with carotid artery stenosis not eligible for endarterectomy: clinical outcome after 5 years., imaj; 10: 121¿124; intraprocedural complications of a cerebrovascular accident (cva) occurred in two patients.The procedure was a carotid artery stenting that was performed with a low profile 4-20mm savvy balloon catheter, which was used for pre-dilatation after administration of 0.6 mg atropine, and then a stent was deployed from the internal to the common carotid.
|