As reported via the (b)(6) registry, a patient experienced a grade c dissection after pre-dilation during a carotid index procedure.Also, reported, patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Pre-procedure nih stroke scale was 2, stroke scale was 1 and the patient was symptomatic.At the time of the index procedure, angiography revealed 95% stenosis to the left proximal internal carotid artery.The lesion was described as concentric.A 6mm angioguard was deployed successfully beyond the target lesion and the lesion was pre-dilated.A 8.0 x 30mm precise pro rx was implanted at the target lesion.It was noted that the angioguard did not malfunction but it was not removed because the patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Concomitant medications included clopidogrel and aspirin at pre-procedure.Per the investigator, the event was not related to the cordis products but related to the index procedure.
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Complaint conclusion: this (b)(6) female enrolled in the sapphire registry study reported via the sapphire registry, a patient experienced a grade c dissection after pre-dilation during a carotid index procedure.Also, reported, patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Pre-procedure nih stroke scale was 2, stroke scale was 1 and the patient was symptomatic.At the time of the index procedure, angiography revealed 95% stenosis to the left proximal internal carotid artery.The lesion was described as concentric.A 6mm angioguard was deployed successfully beyond the target lesion and the lesion was pre-dilated.A 8.0 x 30mm precise pro rx was implanted at the target lesion.It was noted that the angioguard did not malfunction but it was not removed because the patient had a carotid rupture after post dilation of stent resulting in respiratory compromise and death.Concomitant medications included clopidogrel and aspirin at pre-procedure.Per the investigator, the event was not related to the cordis products but related to the index procedure.The patient¿s medical history includes hyperlipidemia,cabg and coronary artery disease.No other information is available.(b)(4).The product remains implanted in the patient and thus not available for evaluation.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Dissection is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.The physical manipulation inherent in the stent implantation procedure intentionally disrupts the vessel plaque and intima in an effort to reconstruct viable patent vasculature and treat the atherosclerotic disease process.Based on the information received, the event was related to the procedure.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.Therefore no corrective and preventive actions will be taken at this time.Carotid artery angioplasty has emerged as a potential therapeutic alternative for atherosclerotic disease.There are several possible complications resulting from the procedure, but carotid artery rupture is very rare, and the management ranges from conservative to open surgery.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.Therefore no corrective and preventive actions will be taken at this time.Without the return of the device for analysis, the reported events could not be confirmed.
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