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

Catalog Number PC1030RXC

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109)

Event Date 12/05/2013

Event Type  Injury  

Manufacturer Narrative

Additional information was provided that the target lesion was located in the ostium of the left internal carotid artery with a stenosis rate of 95%.At discharge the patient's nih and rankin stroke scale scores were both 0.Additional lab results/tests provided: date of maximum ck (b)(6) 2013 2:51 am.Maximum total ck 55.0.Maximum upper limit ck 397.0.Date of maximum ck-mb (b)(6) 2013 02:51 am.Maximum total ck-mb 2.5.Maximum upper limit ck-mb 6.3 ng/ml.Date of first value ck (b)(6) 2013 01:48pm.First value total ck 54.0.First value upper limit ck 397.0.Date of first value ck-mb (b)(6) 2013 01:48 pm.First value total ck-mb 1.3.First value upper limit ck-mb 6.4 ng/ml.Additional concomitant medication: bivarudin was given intra procedure.Please note that the patient's weight has been added: (b)(6).This is one of three products involved with the reported adverse event and the associated manufacturer report numbers are 1016427-2014-00002, and 9616099-2014-00009.Complaint conclusion: according to the (b)(6) study, a patient suffered from a sudden onset of aphasia during the post-dilation with a 5.5x20mm aviator plus balloon catheter after a 10x30mm precise pro rx stent was deployed at the target lesion, which was diagnosed as a transient ischemic attack (tia).The patient also suffered from hypotension and bradycardia, which was treated with neo-synephrine and atropine.The patient fully recovered with no deficits in less than 15 minutes.The patient underwent a cabg surgery 8 days later and was in recovery.The patient was discharged 21 days after the carotid stenting procedure.The patient was a (b)(6) man with a medical history of severe cardiac & carotid disease, two or more proximal or major diseased coronary arteries, type 2 diabetes mellitus, hypertension, and paroxysmal atrial fibrillation on flecainide.After suffering a non-st-elevation mi, the patient was transferred to (b)(6) hospital.During a left heart catheterization and bilateral carotid angiography, a target lesion was found to be located in the ostium of the left internal carotid artery, with a length of 20mm and a diameter of 9mm.The lesion was moderately calcified with 95% stenosis and the vessel was not tortuous.The nihss and rankin stroke scale scores were both 0 and the patient was asymptomatic before the procedure.During the internal carotid stenting procedure, a 7mm angioguard rx embolic protection device was inserted through the left femoral artery and deployed past the target lesion.After the lesion was dilated with a 4mm balloon, a 10x30mm precise pro rx stent was implanted at the target lesion before post-dilation with a 5.5x20mm aviator plus balloon catheter was performed, leaving a final stenosis rate of 20%.However, during the post-dilation, the patient suffered from a sudden onset of aphasia, which was diagnosed as a tia.The patient also suffered from hypotension and bradycardia, which was treated with neo-synephrine and atropine.The physician aspirated for thrombus, however no obvious clots or debris were seen in the filter.The angioguard device was retrieved with confirmation of good antegrade brisk flow, and found to have no debris in the basket.The patient fully recovered with no residual deficits in less than 15 minutes.No ct/mri of the head was taken.The patient underwent a cabg surgery 8 days later and was in recovery.The patient was discharged 21 days after the carotid stenting procedure.At discharge the patient's nih and rankin stroke scale scores were both 0.The device was implanted, and therefore 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 15958866 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Hypotension, bradycardia and the resultant tia are well-known potential adverse events associated with the carotid stent implantation 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.Tia occurs when the blood supply to part of the brain is briefly interrupted.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 results in a fall in blood pressure and bradycardia.Stent placement may promote persistent stimulation of these baro-receptors.These reactions are anticipated relatively short-term adverse events associated with the compression of the baro-receptors during balloon inflation, stent implantation and filter device manipulation.Certain factors may influence the likelihood of anticipated baro-receptor reactions such as advanced age, ventricular dysfunction and gender.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.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 of either device involved.

Event Description

According to the sapphire study, a patient suffered from a sudden onset of aphasia during the post-dilation with a 5.5x20mm aviator plus balloon catheter after a 10x30mm precise pro rx stent was deployed at the target lesion, which was diagnosed as a transient ischemic attack (tia).The patient also suffered from hypotension and bradycardia, which was treated with neo-synephrine and atropine.The patient fully recovered with no deficits in less than 15 minutes.The patient underwent a cabg surgery 8 days later and was in recovery.The patient was discharged 21 days after the carotid stenting procedure.After suffering a non-st-elevation mi, the patient was transferred to (b)(6) hospital.During a left heart catheterization and bilateral carotid angiography, a target lesion was found to be located in the left internal carotid artery, with a length of 20mm and a diameter of 9mm.The lesion was moderately calcified and the vessel was not tortuous.The nihss and rankin stroke scale scores were both 0 and the patient was asymptomatic before the procedure.During the internal carotid stenting procedure, a 7mm angioguard rx embolic protection device was inserted through the left femoral artery and deployed past the target lesion.After the lesion was dilated with a 4mm balloon, a 10x30mm precise pro rx stent was implanted at the target lesion before post-dilation with a 5.5x20mm aviator plus balloon catheter was performed, leaving a final stenosis rate of 20%.However, during the post-dilation, the patient suffered from a sudden onset of aphasia, which was diagnosed as a tia.The patient also suffered from hypotension and bradycardia, which was treated with neo-synephrine and atropine.The physician aspirated for thrombus, however no obvious clots or debris were seen in the filter.The angioguard device was retrieved with confirmation of good antegrade brisk flow, and found to have no debris in the basket.

Manufacturer Narrative

Describe the event or problem): the patient fully recovered with no residual deficits in less than 15 minutes.The patient underwent a cabg surgery 8 days later and was in recovery.The patient was discharged 21 days after the carotid stenting procedure.The product remains implanted and is thus not available for analysis.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.Concomitant medications: heparin, fentanyl, atropine, neo-synephrine, and versed were given during the procedure.Pre and post-procedure medications included amiodarone, aspirin, cetirizine, clopidogrel, docusate, doxycycline hyclate, furosemide, glipizide, insulin lispro, keflex, lipitor, lisinopril, lopressor, metformin, nasonex, percocet, potassium chloride and vitamin d3.Concomitant devices: 7mm angioguard rx, catalog # 701814rmc, lot# 71112434; 5.5x20mm aviator plus balloon catheter, catalogue # 4245520w; cook 7f shuttle sheath; abbott wholey wire; emerge 4x20mm balloon catheter, boston scientific; and 6f pronto for aspiration.This is one of three products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00008, 1016427-2014-00002, and 9616099-2014-00009.

Manufacturer Narrative

This is one of three products involved with the reported adverse event and the associated manufacturer report numbers are 9616099-2014-00008, 1016427-2014-00002, and 9616099-2014-00009.The cec agreed that a tia-ipsilateral occurred and was procedure and device-related.The cec provided the following additional details: the patient was on scheduled for cabg surgery during the same admission, and carotid stenting was done as an endeavor to lower his risk for the said procedure, as stated in the catheterization report.On (b)(6) 2013 at 19:06 he underwent the index procedure with delivery of the angioguard rx ecgw, pre-stent balloon angioplasty and placement of one precise pro stent in the left ostial ica.At the time of post-dilatation, the patient developed expressive aphasia.There was also hypotension noted which was treated with iv fluids.Given this, aspiration for thrombus was performed, but no obvious clots or debris was seen.The angioguard rx ecgw itself was retrieved at 19:35 with confirmation of good antegrade brisk flow into the left mca.The left aca was filled with good cross filling from the patent communicating artery anteriorly in the circle of willis.Aphasia started at 19:29, still remained at 19:32, and at 19:39 was reported to be improving.The site reported a 20% final residual in-lesion stenosis.The catheterization report noted that the patient completely recovered, was conversing with the staff, moving all extremities and squeezing the toy.The procedural events log reported that the patient experienced intra-procedural tia with expressive aphasia which had resolved post filter retrieval.

• 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: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3550169
• MDR Text Key: 11417924
• Report Number: 9616099-2014-00008
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• 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: PC1030RXC
• Device Lot Number: 15958866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 84