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

Catalog Number PC0930RXC

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 03/27/2014

Event Type  Injury  

Event Description

As reported by the (b)(4) study, the patient had persistent hypotension and bradycardia requiring persistent neosynephrine infusion after the procedure.About a month after the procedure, the patient had a sudden onset of behavior changes, aphasia, and dysarthria, which was diagnosed as a transient ischemic attack (tia).The patient fully recovered with no residual deficits in less than 24 hours.The target lesion was located in the ostium of the right internal carotid artery with a length of 10mm and a diameter of 6mm.The eccentric lesion was mildly calcified with 90% stenosis.There was no lesion thrombosis.The vessel was a type iii arch vessel with none documented tortuosity.At baseline, the nih score was 0 and the rankin score was 3 because he requires a care giver to assist him with his daily affairs.The patient was asymptomatic before the procedure.Approach was made with a 7mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then a 9x30mm precise pro rx stent was implanted at the target lesion, leaving a final stenosis rate of 10%.The angioguard device was successfully retrieved and was found to have debris in the basket.There was no presence of air bubbles and the patient did not have a neurological event prior to leaving the angiography suite.The patient was discharged three days later with no major adverse event.However, the patient had an nih score increased to 2 prior to discharge because ¿he was confused when asked his age and month.¿ it is believed that ¿he was just a bit disoriented after spending the night in the hospital.He has a history of being confused or forgetful at times prior to the procedure.There were no other neurological symptoms.¿ his post-procedure course was remarkable for persistent hypotension and bradycardia requiring persistent neosynephrine infusion.At the time of discharge, he was off vasopressor medications.

Manufacturer Narrative

About a month later, the patient had a sudden onset of behavior changes, aphasia and dysarthria, which was later diagnosed as a tia.It was reported that the patient was at home with his care giver when this event occurred.The care giver reported that the patient woke up and was sitting on the side of his bed staring at his hands with associated tremor.He then walked to this doorway where he stood for several minutes.He stood staring at the door jam with his hands trembling.This lasted 5 minutes.He was not able to speak during these moments.He was not responding appropriately.The patient returned to bed and in a few minutes he returned to normal.The patient had no recollection of the event.This happened to be the day that the patient was scheduled to return for his 30 day follow up visit.The patient came to his office visit rather than the hospital.At the time of his visit, he was neurologically intact but had no recollection of the morning¿s events.He returned to his home with the care giver.No documentation was made as to what may have caused this, but it is not believed to be the cordis device or procedure.The 30-day follow-up nih score was 0 and the rankin score remained at 3.Following the office visit, the patient was sent for a stat ct scan of the brain.The result is unchanged from a previous scan.He also had an ekg which was normal.The device remains implanted in the patient; therefore it is not available for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.Concomitant medications: bivalirudin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.Neosynephrine was given post-procedure.Concomitant devices: 7mm angioguard catalog number 701814rmc, lot number 35220458.

Manufacturer Narrative

Complaint conclusion: as reported by the (b)(4) study, the patient was a (b)(6) male with a medical history of coronary artery disease, coronary percutaneous revascularization, and hypertension.He has a history of being confused or forgetful at times prior to the procedure.The target lesion was located in the ostium of the right internal carotid artery with a length of 10mm and a diameter of 6mm.The eccentric lesion was mildly calcified with 90% stenosis.There was no lesion thrombosis.The vessel was a type iii arch vessel with none documented tortuosity.At baseline, the nih score was 0 and the rankin score was 3 because he requires a care giver to assist him with his daily affairs.The patient was asymptomatic before the procedure.Approach was made with a 7mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then a 9x30mm precise pro rx stent was implanted at the target lesion, leaving a final stenosis rate of 10%.The angioguard device was successfully retrieved and was found to have debris in the basket.There was no presence of air bubbles and the patient did not have a neurological event prior to leaving the angiography suite.The patient was discharged three days later with no major adverse event.However, the patient had an nih score increased to 2 prior to discharge because ¿he was confused when asked his age and month.¿ it is believed that ¿he was just a bit disoriented after spending the night in the hospital.He has a history of being confused or forgetful at times prior to the procedure.There were no other neurological symptoms.¿ his post-procedure course was remarkable for persistent hypotension and bradycardia requiring persistent neosynephrine infusion.At the time of discharge, he was off vasopressor medications.About a month later, the patient had a sudden onset of behavior changes, aphasia and dysarthria, which was later diagnosed as a tia.It was reported that the patient was at home with his care giver when this event occurred.The care giver reported that the patient woke up and was sitting on the side of his bed staring at his hands with associated tremor.He then walked to this doorway where he stood for several minutes.He stood staring at the door jam with his hands trembling.This lasted 5 minutes.He was not able to speak during these moments.He was not responding appropriately.The patient returned to bed and in a few minutes he returned to normal.The patient had no recollection of the event.This happened to be the day that the patient was scheduled to return for his 30 day follow up visit.The patient came to his office visit rather than the hospital.At the time of his visit, he was neurologically intact but had no recollection of the morning¿s events.He returned to his home with the care giver.No documentation was made as to what may have caused this, but it is not believed to be the cordis device or procedure.The 30-day follow-up nih score was 0 and the rankin score remained at 3.Following the office visit, the patient was sent for a stat ct scan of the brain.The result is unchanged from a previous scan.He also had an ekg which was normal.Duplex ultrasound on 04/24/2014 demonstrated a patent study stent in the right carotid artery and no significant elevation of velocities in either carotid artery.The device remains implanted in the patient; therefore, it is not available for analysis.A device history record (dhr) review of lot 15983750 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Hypotension and bradycardia are well-known potential adverse events associated with the carotid stent implantation procedure.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.A tia is a well-known potential adverse event associated with the carotid stent implantation procedure and is listed in the ifu as such.A tia occurs when the blood supply to part of the brain is briefly interrupted.The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may flow downstream potentially disrupting perfusion both during and after carotid stent implantation.Tia symptoms are similar to those of stroke but do not last as long.By definition ((b)(6)), the symptoms of a tia may last up to 24 hours, but they often last only a few minutes.Certain factors may influence the likelihood of anticipated baro-receptor reactions such as advanced age, ventricular dysfunction and gender.Behavior changes, dysarthria, and aphasia, as symptoms of a tia, are well-known potential adverse events associated with the carotid stent.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient and vessel 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 event does not appear to be related to the manufacturing process of the products involved.

• 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: 4010825
• MDR Text Key: 4957803
• Report Number: 9616099-2014-00530
• 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
• Report Date: 04/25/2014

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: 09/30/2015
• Device Catalogue Number: PC0930RXC
• Device Lot Number: 15983750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2014
• Initial Date FDA Received: 08/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: 84 YR
• Patient Weight: 73