MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM)

Catalog Number PC0940RXC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109)

Event Date 03/27/2014

Event Type  Injury  

Event Description

As reported by the (b)(4) study, the patient had hypotension at the time the precise pro rx stent was implanted.The patient received a levophed drip throughout the procedure and during the night before, the patient was discharged.About two hours after discharge, the patient suffered from a sudden onset of blurred vision in both eyes and a bad headache, which was diagnosed as a transient ischemic attack (tia).It was reported that the hypotension is believed to be the cause of the tia.The patient was admitted to the er and received iv fluids.The patient fully recovered with no residual deficits within 4 hours of onset and was discharged the next day.The target lesion was located in the ostium of the left internal carotid artery with a length of 21.3 and a diameter of 5.79mm.The eccentric lesion was mildly calcified in a concentric manner with 85% stenosis.There was no lesion thrombosis.The vessel was a type i arch vessel with none documented tortuosity.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was asymptomatic before the procedure.Approach was made with a 6mm angioguard rx embolic protection device, with was successfully deployed past the lesion before pre-dilation was performed.Then, a 9x40mm precise pro rx stent was deployed at the lesion, leaving a final stenosis rate of 0%.After deployment of the precise stent, the patient suffered from hypotension.The patient was given levophed drip throughout the procedure, which was reported to be quite common.There was none documented presence of air bubbles and the patient did not have a neurological deficit prior to leaving the angiography suite.The patient remained on the levophed drip during the night and was weaned off later the next day.The patient was discharged the next day with the nih and rankin stroke scale scores at 0.

Manufacturer Narrative

Later that day, about 24 hours after the carotid artery stenting procedure and 3 hours after discharge (1 hour to drive home and 2 hours spent at home), the patient suffered from a sudden onset of blurred vision in both eyes and a bad headache.The patient was advised to go to the local hospital er, and was transferred back to the er in which the patient had the procedure.The patient was diagnosed with a tia, which is believed to be caused by hypotension.Upon presenting with tia, no hypotension was present.It was reported that they attributed the signs and symptoms to being hypotension without having an actual bp check.The tia was reported not related to the cordis device or the index procedure.The symptoms had resolved on their own prior to the patient arriving to the facility where he had the stenting procedure.The patient was given iv fluids, and was monitored overnight.The patient had fully recovered within 4 hours of onset and was discharged the day after onset began.The patient is at home without complaints.The device remains implanted in the patient; therefore it is not available for analysis.The device history record (dhr) review and additional information are pending and will be submitted 30 days upon receipt.Concomitant medications: heparin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.Levophed was given during and after the procedure.Concomitant devices : 6mm angioguard rx catalog number 601814rmc, lot number 35220133.

Manufacturer Narrative

This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00278 and 1016427-2014-00050.All other information remains unchanged.Additional information is pending and will be submitted 30-days upon receipt.

Manufacturer Narrative

Additional information: at the 30-day follow-up visit, the patient had and nih and rankin score of 0 with no additional adverse events reported.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00278 and 1016427-2014-00050.Complaint conclusion: as reported by the sapphire study, the patient had hypotension at the time the precise pro rx stent was implanted.The patient received a levophed drip throughout the procedure and during the night before the patient was discharged.About two hours after discharge, the patient suffered from a sudden onset of blurred vision in both eyes and a bad headache, which was diagnosed as a transient ischemic attack (tia).It was reported that the hypotension is believed to be the cause of the tia.The patient was admitted to the er and received iv fluids.The patient fully recovered with no residual deficits within 4 hours of onset and was discharged the next day.The patient was a (b)(6) male with a medical history or an abnormal stress test, coronary artery disease, hypertension and hyperlipidemia.The target lesion was located in the ostium of the left internal carotid artery with a length of 21.3 and a diameter of 5.79mm.The eccentric lesion was mildly calcified in a concentric manner with 85% stenosis.There was no lesion thrombosis.The vessel was a type i arch vessel with none documented tortuosity.The nih and rankin stroke scale scores were both 0 at baseline, and the patient was asymptomatic before the procedure.Approach was made with a 6mm angioguard rx embolic protection device, with was successfully deployed past the lesion before pre-dilation was performed.Then, a 9x40mm precise pro rx stent was deployed at the lesion, leaving a final stenosis rate of 0%.After deployment of the precise stent, the patient suffered from hypotension.The patient was given levophed drip throughout the procedure, which was reported to be quite common.There was none documented presence of air bubbles and the patient did not have a neurological deficit prior to leaving the angiography suite.The patient remained on the levophed drip during the night and was weaned off later the next day.The patient was discharged the next day with the nih and rankin stroke scale scores at 0.Later that day, about 24 hours after the carotid artery stenting procedure and 3 hours after discharge (1 hour to drive home and 2 hours spent at home), the patient suffered from a sudden onset of blurred vision in both eyes and a bad headache.The patient was advised to go to the local hospital er, and was transferred back to the er in which the patient had the procedure.The patient was diagnosed with a tia, which is believed to be caused by hypotension.Upon presenting with tia, no hypotension was present.It was reported that they attributed the signs and symptoms to being hypotension without having an actual bp check.The tia was reported not related to the cordis device or the index procedure.After onset of the symptoms, a ct with & w/o contrast was performed: ¿no evidence of acute intracranial processes.¿ the symptoms had resolved on their own prior to the patient arriving to the facility where he had the stenting procedure.The patient was given iv fluids, and was monitored overnight.The patient had fully recovered within 4 hours of onset and was discharged the day after onset began.The patient is at home without complaints.At the 30-day follow-up visit, the patient had and nih and rankin score of 0 with no additional adverse events reported.The device remains implanted; therefore, the device was not available for analysis.A device history record (dhr) review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15958879 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Hypotension and a tia are a well-known potential adverse events associated with the carotid stent implantation procedure and in listed in the ifu as such.The hemodynamic instability that occurs both during and after carotid stent implantation is influenced by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds (stent delivery system) and distal protection devices, initiating a reflex via the glossopharyngeal nerve.This can result in a fall in blood pressure, which could become hypotension.This reaction is an anticipated relatively short-term adverse event associated with the compression of the baro-receptors during stenting procedure.Tia symptoms are similar to those of stroke but do not last as long.Typically symptoms of a tia often last only a few minutes, most symptoms resolve within an hour but they may last up to 24 hours.A tia occurs when the blood supply to part of the brain is briefly interrupted.Stent placement may promote persistent stimulation of the carotid baro-receptors, and therefore causing a reaction that may lower blood pressure and heart rate; thus, interrupting blood flow to the brain.Certain factors may influence the likelihood of anticipated baro-receptor reactions such as advanced age, ventricular dysfunction and gender.There is no evidence to suggest that the events are related to the design or manufacturing process of the device.Review of the available information suggests that patient factors and/or vessel/lesion characteristics may have contributed to the event.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported events do not appear to be related to the manufacturing process.

Manufacturer Narrative

Correction: please note that the date of the event has been corrected to (b)(6) 2014.The previously reported event date provided in the initial medwatch (mdr) report was inadvertently provided incorrectly.All other information provided remains unchanged.The clinical events committee (cec) agreed that a tia- non-ipsilateral occurred and was procedure-related.Additional information was provided by the cec: the angioguard rx ecgw was retrieved with debris found in the filter.The site reported no post-procedure maes.On the way home on (b)(6) 2014 the patient started having blurred vision in both eyes.Per physician's note, he had double-vision and blurred vision bilaterally, worse in the left eye than right.He felt his vision was cloudy.He also started to develop a quite severe headache.The symptoms lasted for 2-2.5 hours.The patient presented to the emergency department on (b)(6) 2014.By the time he arrived to the emergency department, his symptoms had resolved and he remained asymptomatic.He was grossly asymptomatic, per neurological exam notes.A cta performed revealed interval placement of the left ica stent with interval resolution of proximal left ica stenosis.The patient was discharged on (b)(6) 2014 with diagnosis of tia.Additional lab results/tests provided: a head ct scan on (b)(6) 2014 revealed no evidence of acute intracranial processes, noting generalized parenchyma volume loss.Cta of the neck on (b)(6) 2014, compared to pre-procedure carotid ultrasound, revealed interval placement of the left ica stent with interval resolution of proximal left ica stenosis.Additional information was received from the study coordinator: "there is an endovascular stent present in the region of the left internal carotid artery extending from the distal left common carotid artery into the left internal carotid artery proximally.No hemodynamically significant stenosis involving the proximal left ica is noted.There is soft tissue and densely calcified plaque at the right carotid bifurcation and involving the proximal left internal carotid artery which results in focal approximately 50% stenosis at the origin of the right internal carotid artery.The distal internal carotid arteries bilaterally are otherwise patent.Impression: interval placement of the left ica stent with interval resolution of proximal left ica stenosis.Approximately 50% stenosis at the origin of the right ica due to eccentric low-attenuation and partially calcified plaque." there is no stenosis noted in the proximal left ica.The 50% stenosis refers to the right ica.Nothing was done to treat the right or left ica's post cas procedure as the stent remained open on the left and the right side doesn't have enough stenosis yet to require treatment.This is one of two products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00278 and 1016427-2014-00050.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3758984
• MDR Text Key: 4480924
• Report Number: 9616099-2014-00278
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 15958879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2014; 05/07/2014; 06/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 129