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 Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/05/2014

Event Type  Injury  

Manufacturer Narrative

This is one of four products involved with the reported adverse event and are associated manufacturer report numbers 9616099-2014-00248, 1016427-2014-00039, 9616099-2014-00249 & 9616099-2014-00250.Complaint conclusion: as reported by (b)(4) the patient had procedure-related hypotension and intermittent bradycardia during the index procedure.The bradycardia developed post pre-dilatation.Hypotension developed post-dilatation.This extended the hospitalization.This was treated with atropine and dopamine.The patient developed dizziness.As per the principal investigator (pi), the dizziness was "an expected sequelae of the combination of hypotension and bradycardia." there were no neurological symptoms associated with the event.The patient was discharged home three days later.Pre-procedure nih stroke scale score was 0 and rankin score was 0.Carotid artery stenting (cas) was performed on an 80% occluded lesion in the right internal carotid artery of 10mm in length in a 6.0mm vessel diameter with severe vessel calcification.The arch i lesion had no documented tortuosity.There was an occlusion in the contralateral carotid.A 7mm basket angioguard embolic protection device was deployed past the lesion and the lesion was pre-dilated with a 4.0x20mm aviator plus balloon.A 10x30mm precise pro rx stent was successfully deployed at the target lesion.The lesion was post-dilated with a 5.5x20mm aviator plus balloon.There was no debris found in the filter basket upon retrieval.The residual diameter stenosis measured 0%.There was no documented presence of air bubbles.The patient was discharged home approximately three days post-procedure.Nih stroke scale was 0 and rankin score was 0.The (b)(6) male patient has a medical history of diabetes mellitus, coronary artery disease, hypertension, and high-risk criteria of contralateral carotid occlusion.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.Review of lot 16023436 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 influence by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds, 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.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.There is no evidence that the event was related to a manufacturing issue, therefore, no corrective action will be taken.

Manufacturer Narrative

This device is not available for testing and evaluation as the device remains implanted.Additional information is pending and will be submitted within 30 days on receipt.This is one of four products involved with the reported adverse event and are associated manufacturer report numbers 9616099-2014-00248, 1016427-2014-00039, 9616099-2014-00249 & 9616099-2014-00250.Concomitant medications: bivalirudin, atropine, and dopamine were given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.Concomitant devices: angioguard rx catalog number 701814rmc, lot number 35220458, aviator plus 4.0x20mm (pre) and aviator plus 5.5x20mm (post).

Event Description

As reported by the (b)(4) registry the patient had procedure-related hypotension and intermittent bradycardia during the index procedure.The bradycardia developed post pre-dilatation.Hypotension developed post-dilatation.This extended the hospitalization.This was treated with atropine and dopamine.The patient developed dizziness.As per the principal investigator (pi), the dizziness was "an expected sequelae of the combination of hypotension and bradycardia." there were no neurological symptoms associated with the event.The patient was discharged home three days later.Pre-procedure nih stroke scale score was 0 and rankin score was 0.Carotid artery stenting (cas) was performed on an 80% occluded lesion in the right internal carotid artery of 10mm in length in a 6.0mm vessel diameter with severe vessel calcification.The arch i lesion had no documented tortuosity.There was an occlusion in the contralateral carotid.A 7mm basket angioguard embolic protection device was deployed past the lesion and the lesion was pre-dilated with a 4.0x20mm aviator plus balloon.A 10x30mm precise pro rx stent was successfully deployed at the target lesion.The lesion was post-dilated with a 5.5x20mm aviator plus balloon.There was no debris found in the filter basket upon retrieval.The residual diameter stenosis measured 0%.There was no documented presence of air bubbles.The patient was discharged home approximately three days post-procedure.Nih stroke scale was 0 and rankin score was 0.

• 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: 3737375
• MDR Text Key: 15882580
• Report Number: 9616099-2014-00248
• 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
• Report Date: 03/19/2014

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: PC1030RXC
• Device Lot Number: 16023436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 04/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2014
• 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
• Patient Age: 73 YR
• Patient Weight: 88