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

Catalog Number PC0840RXC

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

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

Event Date 02/20/2014

Event Type  Injury  

Manufacturer Narrative

Complaint conclusion: as reported by the (b)(4) registry the same day following the index procedure the patient had a transient ischemic attack (tia).Onset was sudden and recovery full with no deficit.Duration was less than 24 hours.Emergency cea surgery was not performed.The event was unrelated to the cordis product and index procedure.Postoperatively, the patient was transferred to the neuroscience intensive care unit.The patient did have some aphasia and a right facial droop.When the patient¿s systolic blood pressure dropped into the 90s, she was given a fluid bolus, albumin, and started on neo-synephrine for blood pressure support.The patient had complete resolution of her facial droop with an increase in her systolic blood pressure to 140.However, she did have some sustained aphasia.The patient¿s blood pressure goals were slightly loosened and she was able to be weaned from her neo-synephrine drip.A renal ultrasound was performed that was unremarkable.The patient remained hemodynamically and neurologically stable and was subsequently transferred to the general neurosurgical floor.Physical and occupational therapy followed the patient throughout her stay, was recommending discharge back to the patient¿s previous living arrangement.The patient¿s aphasia had resolved completely prior to discharge.The patient was discharged 6 days post index procedure.Patient still had a slight visual field defect upon discharge but this was present due to the stroke she had prior to the precise stent placement.It was the reason for admission to the hospital.Pre-procedure nih stroke scale score was 2 and rankin score was 0.The patient was symptomatic.There was an occlusion in the contralateral carotid.Carotid artery stenting (cas) was performed on an 80% occluded lesion in the proximal right internal carotid artery of 15mm in length in a 5.3mm vessel diameter with mild vessel tortuosity.The arch iii lesion was mildly calcified and ulcerated.A 5mm basket angioguard embolic protection device was deployed past the lesion and the lesion was pre-dilated with a 5x40mm aviator balloon.An 8x40mm precise pro rx stent was successfully deployed at the target lesion.Post angiography demonstrated that there was residual stenosis.Therefore, post stent angioplasty was performed with a 6x30mm aviator balloon.The residual diameter stenosis measured 0%.Debris was 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.Nih stroke scale score was 2 and rankin score was 0.The (b)(6) female patient has a medical history of homonymous hemianopsia, severe iron-deficiency anemia, right occipitoparietal cerebrovascular infarct with left ica occlusion and high grade severe right ica stenosis, hypertension, previous aorto birfurcation bypass , and high-risk criteria: contralateral carotid occlusion.The product 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 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.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.There is no evidence that manufacturing issues contributed to the event.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

Adjudication minutes were received and determined that the patient experienced an ipsilateral and non-ipsilateral cva the same day following stent placement.The site had reported the patient had a tia.There is not enough information/evidence included in the adjudication minutes to support removal of this determination.As such, there is no change to the file.The additional information provided is as follows: one day following the index procedure, per neurosurgery ip progress note, at the time of consultation the patient had some residual aphasia; her speech was slurred at times, and there was complete resolution of facial droop.Neurosurgery progress note two days following index procedure reported that the patient denied aphasic and facial involvement.She was oriented to self, place, president, and named objects; cn ii-xii was reported as grossly intact.Her face was symmetric.Symmetric strength with no drift was noted.Neurosurgery progress note four days post index procedure reported cn ii-xii grossly intact, noted left inferior quadrantanopia.The discharge summary reported that the patient¿s aphasia had resolved completely prior to discharge.The site reported tia with duration of deficits less than 24 hours.Pre-discharge, the nih stroke scale score was 2 due to complete hemianopia, and the rankin stroke scale score was 0.The patient was discharged six days post index procedure on asa and clopidogrel.

• 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: 3682441
• MDR Text Key: 11567658
• Report Number: 9616099-2014-00194
• 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
• Report Date: 02/20/2014

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: 10/31/2015
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 16019165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 03/17/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/28/2014; 06/16/2014
• 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): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 64 YR
• Patient Weight: 45