As reported by the (b)(6) registry, during a carotid artery stenting (cas) procedure a carotid artery spasm was noted during deployment of a 9x40mm precise pro rx stent.It was also noted that the stent became compressed in the patient.A second precise pro rx was deployed overlapping the first stent.Cas was performed on a 90% occluded lesion in the ostium of the left internal carotid artery of 20mm in length in a 9.0mm vessel diameter with moderate vessel tortuosity.The lesion was eccentric and moderately calcified.A 6mm extra support embolic protection device was deployed past the lesion and a 9x40mm precise stent was deployed.The stent became compressed after a carotid artery spasm occurred as depicted by an angiogram showing a narrowing at the proximal end of the stent.A second precise pro rx was deployed overlapping the first stent with a residual diameter stenosis measured at 10%.The patient was neurologically intact upon leaving the angio suite.The patient was discharged on the following day with no reported patient injury.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Vessel spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature and is listed in the ifu (instructions for use) as such.Local vasospasm can be caused by the outward radial force and axial friction of the stent, or by the device manipulations inherent in any procedure causing endothelial irritation.A carotid vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow to the brain.This may lead to tia like symptoms such as muscular or neurological changes.Treatment of arterial spasms may include medications such as nitrates and calcium channel blockers.It was also noted that the stent became compressed after the carotid artery spasm occurred as depicted by an angiogram showing a narrowing at the proximal end of the stent.A second precise pro rx was deployed overlapping the first stent.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.The product was not returned for analysis.Based on the lack of information and the inability to assign or determine a root cause no corrective actions will be taken at this time.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00271 and 1016427-2014-00047.
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This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.J wire, ima catheter, 5f sheath, 6f 90 cm sheath, 6mm angioguard, 8x30mm precise stent and mynx closure device.Concomitant medications: heparin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00271 and 1016427-2014-00047.
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