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

Catalog Number PC0730RXC

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

Patient Problems Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914)

Event Date 03/03/2014

Event Type  Death  

Event Description

As reported by the (b)(4) registry, the patient expired approximately 6 days following the index procedure.According to the death record (critical care event note), the cause of death was cardiopulmonary failure.Secondary causes include severe cardiomyopathy, aortic stenosis, and respiratory failure.The event was deemed unrelated to the device and index procedure.No autopsy was performed.The carotid stent procedure went well without complications "except for a low blood pressure which is expected." the first hypotension occurred after pre dilatation and stent deployment.The stent balloon (5 x 20 aviator plus) was removed at 13:06 and the first recorded low bp was at 13:06 the post dilatation balloon (6 x 20 aviator plus balloon) was inserted at 13:10.The patient was put on levophed and transferred to the icu in good condition alert and oriented.After arriving in the icu, the patient became agitated and short of breath and eventually became hypoxic with pea and then arrested.Pre-procedure nih stroke scale score was 0 and rankin score was 0.The patient was asymptomatic at baseline.Carotid artery stenting (cas) was performed on a 90% occluded lesion in the ostial left internal carotid artery of 15mm in length in a 6.0mm vessel diameter with moderate vessel tortuosity.The arch ii lesion was mildly calcified and eccentric.A 5mm basket angioguard embolic protection device was deployed past the lesion and the lesion was pre-dilated.A 7x30mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 25%.There was no debris found in the filter basket upon retrieval.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient expired 6 days following the index procedure.

Manufacturer Narrative

This is one of three products involved with the reported adverse events and are associated manufacturer report numbers 9616099-2014-00212, 1016427-2014-00033 & 9616099-2014-00213.This device is not available for testing and evaluation as it remains implanted.Additional information is pending and will be submitted within 30 days upon receipt.Concomitant medications: levophed was given during the procedure.Concomitant devices: angioguard rx catalog number 501814rmc, lot number 70812438, aviator plus 424-5020w 5 x 20 mm and lot 15760324 (pre-dilatation), aviator plus 424-6020w 6 x 20 mm and lot 15757108 (post-dilatation).

Manufacturer Narrative

Correction: the patient's baseline nih stroke scale score and rankin score were inadvertently submitted as 0 and 0; however, the nih stroke scale score was 1 and the rankin score was 1 pre-procedure.This is one of three products involved with the reported adverse events and are associated manufacturer report numbers 9616099-2014-00212, 1016427-2014-00033 & 9616099-2014-00213.Adjudication minutes were received and reviewed.The cec agreed that the contributing etiology for the patient¿s death was cardiac in origin and was procedure-related.Additional details were received from the (b)(6) that the site also reported history of severe aortic stenosis, status post valvuloplasty with minimal improvement and severe cardiomyopathy.Pre-procedure, the nih stroke scale score was 1 and the rankin stroke scale score was 1.Post-stent procedure the patient developed respiratory insufficiency and cardiac arrest with pulseless electrical activity.He was emergently intubated.Multiple pressors were started.Further the patient was placed on milrinone infusion.The hospital course was complicated by leukocytosis, acute renal failure, peripheral edema, and anemia requiring transfusion of blood.The patient remained unresponsive even as he was off sedatives.A head ct scan was performed and was found to be negative.The site reported anoxic encephalopathy.The prognosis was poor, and the family made a decision to change the status to dnr.The patient expired 6 days post-procedure.The site reported the cause of death as cardiac due to other.The critical care event note reported the cause of death as cardiopulmonary failure, noting secondary causes as severe cardiomyopathy, aortic stenosis, and respiratory failure.

Manufacturer Narrative

This is one of three products involved with the reported adverse events and are associated manufacturer report numbers 9616099-2014-00212, 1016427-2014-00033 & 9616099-2014-00213.Complaint conclusion: as reported by the sapphire registry the patient expired approximately 6 days following the index procedure.According to the death record (critical care event note), the cause of death was cardiopulmonary failure.Secondary causes include severe cardiomyopathy, aortic stenosis, and respiratory failure.The event was deemed unrelated to the device and index procedure.No autopsy was performed.The carotid stent procedure went well without complications "except for a low blood pressure which is expected." the first hypotension occurred after pre dilatation and stent deployment.The stent balloon (5 x 20 aviator plus) was removed at 13:06 and the first recorded low bp was at 13:06 the post dilatation balloon (6 x 20 aviator plus balloon) was inserted at 13:10.The patient was put on levophed and transferred to the icu in good condition alert and oriented.After arriving in the icu, the patient became agitated and short of breath and eventually became hypoxic with pulseless electrical activity (pea) and then arrested.Pre-procedure nih stroke scale score was 0 and rankin score was 0.The patient was asymptomatic at baseline.Carotid artery stenting (cas) was performed on a 90% occluded lesion in the ostial left internal carotid artery of 15mm in length in a 6.0mm vessel diameter with moderate vessel tortuosity.The arch ii lesion was mildly calcified and eccentric.A 5mm basket angioguard embolic protection device was deployed past the lesion and the lesion was pre-dilated.A 7x30mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 25%.There was no debris found in the filter basket upon retrieval.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient expired 6 days following the index procedure.The (b)(6) male patient has a medical history of severe pulmonary disease, first-degree relative with premature cad (female <65 y.O.Or male <55 y.O.), clinical copd, history of smoking (>5packs of cigarettes), diabetes mellitus, coronary percutaneous revascularization, hypertension, right carotid stenosis 40%, and high risk criteria: severe pulmonary disease and age > 75.The device was not returned for analysis as it remains implanted.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.Hypotension is a well-known potential adverse event 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.Certain factors may influence the likelihood of anticipated baro-receptor reactions such as advanced age, ventricular dysfunction and gender.Sudden cardiac arrest is the sudden, unexpected loss of heart function, breathing and consciousness.Sudden cardiac arrest usually results from an electrical disturbance in your heart that disrupts its pumping action, stopping blood flow to the rest of your body.Sudden cardiac arrest is different from a heart attack, which occurs when blood flow to a portion of the heart is blocked.However, a heart attack can sometimes trigger an electrical disturbance that leads to sudden cardiac arrest.Sudden cardiac arrest is a medical emergency.If not treated immediately, it causes sudden cardiac death.There is no evidence that manufacturing issues contributed to the events reported.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.Therefore, no corrective actions will be taken at this time.

• 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: 3698326
• MDR Text Key: 4334642
• Report Number: 9616099-2014-00212
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: PC0730RXC
• Device Lot Number: 15750004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 78