MAUDE Adverse Event Report: CORDIS CORPORATION 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 Stroke/CVA (1770); Embolus (1830); Thrombosis (2100)

Event Date 04/11/2016

Event Type  Injury  

Manufacturer Narrative

Please note that the gender of the patient is unknown.(b)(4).Concomitant products and devices: nitroglycerine during the procedure.Angioguard rx, catalog # 601814rmc; aviator balloon catheters, 4244020w, 4245020w, and 4246020w.The device remains implanted in the patient, therefore it is not available to be returned for analysis.A device history record (dhr) review could not be conducted as a lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.This is one of two products involved with the reported adverse events and the associated manufacturer report numbers are 9616099-2016-00209 and 1016427-2016-00011.

Event Description

As reported, after deployment of the angioguard, an arterial spasm occurred.It was treated with nitroglycerine.During pre-dilation with the 4x20mm aviator, the filter became full.After stent implantation, the physician said that clots developed in the stent and soft plaque came through the struts of the stent, and embolized, causing a stroke.The patient was treated.There was no difficulty deploying or using the devices.When the angioguard was deployed distal to the lesion, an arterial spasm occurred.The physician stated that it was possibly related to the size of the angioguard.The patient was treated with nitroglycerine and the spasm cleared.During pre-dilation with the 4x20mm aviator balloon, the angioguard filter became full, showing slow flow.The precise stent was implanted successfully and the angioguard was removed.The patientflow improved.However, scans taken after the procedure showed clots forming in the implanted precise stent.The physician said the patient had an act of 290, but the clots continued to form.The patient then had a stroke (embolic).The physician also stated that the patient had many medical problems that also could have led to the stroke that occurred.He does not have any of the lot numbers for the devices reported.

Manufacturer Narrative

This is one of two products involved with the reported adverse events and the associated manufacturer report numbers are 9616099-2016-00209 and 1016427-2016-00011.Complaint conclusion: as reported, after deployment of the angioguard, an arterial spasm occurred.It was treated with nitroglycerine.During pre-dilation with the 4x20mm aviator, the filter became full.After stent implantation, the physician said that clots developed in the stent and soft plaque came through the struts of the stent, and embolized, causing a stroke.The patient was treated.There was no difficulty deploying or using the devices.When the angioguard was deployed distal to the lesion, an arterial spasm occurred.The physician stated that it was possibly related to the size of the angioguard.The patient was treated with nitroglycerine and the spasm cleared.During pre-dilation with the 4x20mm aviator balloon, the angioguard filter became full, showing slow flow.The precise stent was implanted successfully and the angioguard was removed.The patient¿s flow improved.However, scans taken after the procedure showed clots forming in the implanted precise stent.The physician said the patient had an act of 290, but the clots continued to form.The patient then had a stroke (embolic).The physician also stated that the patient had many medical problems that also could have led to the stroke that occurred.He does not have any of the lot numbers for the devices reported.The devices were not returned for analysis.A device history record (dhr) review could not be conducted as a lot number was not provided.A vessel spasm is a known potential adverse event associated with any interventional procedure where devices are introduced into the vasculature and is listed in the ifu (instructions for use) as such.This can occur due to stimulated baro-receptors from interventional balloons, sds (stent delivery system) and distal protection devices.Treatment of the arterial spasm with nitroglycerine is a usual practice in order to continue the procedure as needed.Stent thrombosis is a known potential adverse event associated with stent implantation procedures and is listed in the ifu as such.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation inside of the stent.When a part of the thrombosis dislodges, it can embolize (a blood clot that forms elsewhere in the body and travels through the bloodstream to the brain) and travel to the neck or brain and block a blood vessel.This is called an embolic stroke.An embolic stroke is well documented potential complication of carotid artery interventions and is listed in the ifu as such.Embolic strokes often result from heart disease or heart surgery and occur rapidly and without any warning signs.About 15 percent of embolic strokes occur in people with atrial fibrillation.Review of the available information suggests that patient factors, vessel/lesion characteristics and/or procedural factors may have contributed to the event.Without a lot number to conduct a dhr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore no corrective and preventive 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 CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5618497
• MDR Text Key: 43982647
• Report Number: 9616099-2016-00209
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PC0840RXC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability