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 Problem Paresis (1998)

Event Date 06/25/2014

Event Type  Injury  

Event Description

During carotid stenting of the left carotid artery with a 5mm angioguard embolic protection device and an 8x40mm precise stent, after deployment of the precise stent, it did not fully expand.Upon further review, it was noted that the devices did not enter the target lesion but were in a side branch.The patient was also not responsive on the right hand and foot.Another stent was deployed in the ica.Access was via the right groin.It was a type 1 arch with ct pictures prior to case.There was approximately 70% stenosis in the ica 1.5cm above the bifurcation.The lesion length was approximately 2cm.Approximately 7000 units of heparin was given and act was 217.The physician utilized a glide wire to position the sheath in the common carotid.Both physicians believed that the 5mm angioguard tracked up the common carotid and into the distal ica.Once the angioguard was deployed, the physicians saw 4 markers separate as a confirmation.Following the deployment of the angioguard, an 8x40 precise rx was inserted and positioned over the lesion as it was road mapped on the monitor.When the stent was deployed the proximal end of the stent about 20mm was fully expanded in the cca however beyond the bifurcation the stent only opened about 2mm in diameter the rest of the 20mm of the stent.At first the physicians believed it was a faulty stent but when they took further images at different angles they realized that the angioguard and stent never entered the ica and could have been either outside of the ica or subintimal of the ica.Further neuro checks were done to the patient left hand and feet were responsive but right side was not.At this time the lesion in the ica has not been touched.One of the physician¿s recommended to recapture the angioguard in the recapturing sheath and reposition it in the ica by going through the struts of the 8x40 already deployed precise stent.They had successfully gotten through a strut of the stent.

Manufacturer Narrative

Event description continued: and placed the 5mm angioguard in the distal ica.The next step was to create a large enough space to deliver another stent in the cca/diseased ica.Another physician took a 5x20 aviator balloon and positioned it 10mm in the stent (in the cca) and 10mm in the ica.The goal was to crack an opening the 8x40 precise stent strut.An angiogram was taken and it looked to have an opening to be able to deliver a new 8x30 precise stent in the cca/ica.The stent was successfully deployed and was post dilated with the 5x20 aviator balloon.Devices removed and no closure was used.After the case, the physicians believed that the vessels were perforated or gone subintimal.They discussed the case and could not believe that the angioguard had perforated or gone subintimal.There was no resistance when they initially tracked the angioguard up what they had thought was the ica.With further review of the films, they noticed that there was a small side branch 5mm beyond the bifurcation in the ica (just below the lesion) that ran parallel with ica.In the road map view that the operators were looking at and working with, it looked as if they were tracking up the ica there fore they deployed the angioguard and stent in the side branch.No films have been acquired other than 2 still pictures of the discreet side branch that was the culprit.(b)(4).The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 1016427-2014-00078 and 9616099-2014-00471.

Manufacturer Narrative

During carotid stenting of the left carotid artery with a 5mm angioguard embolic protection device and an 8x40mm precise stent, after deployment of the precise stent, it did not fully expand.Upon further review, it was noted that the devices did not enter the target lesion but were in a side branch.The patient was also not responsive on the right hand and foot.Another stent was deployed in the ica.Access was via the right groin.It was a type 1 arch with ct pictures prior to case.There was approximately 70% stenosis in the ica 1.5cm above the bifurcation.The lesion length was approximately 2cm.Approximately 7000 units of heparin was given and act was 217.The physician utilized a glide wire to position the sheath in the common carotid.Both physicians believed that the 5mm angioguard tracked up the common carotid and into the distal ica.Once the angioguard was deployed, the physicians saw 4 markers separate as a confirmation.Following the deployment of the angioguard, an 8x40 precise rx was inserted and positioned over the lesion as it was road mapped on the monitor.When the stent was deployed the proximal end of the stent about 20mm was fully expanded in the cca however beyond the bifurcation the stent only opened about 2mm in diameter the rest of the 20mm of the stent.At first the physicians believed it was a faulty stent but when they took further images at different angles they realized that the angioguard and stent never entered the ica and could have been either outside of the ica or subintimal of the ica.Further neuro checks were done to the patient left hand and feet were responsive but right side was not.At this time the lesion in the ica has not been touched.One of the physician¿s recommended to recapture the angioguard in the recapturing sheath and reposition it in the ica by going through the struts of the 8x40 already deployed precise stent.They had successfully gotten through a strut of the stent and placed the 5mm angioguard in the distal ica.The next step was to create a large enough space to deliver another stent in the cca/diseased ica.Another physician took a 5x20 aviator balloon and positioned it 10mm in the stent (in the cca) and 10mm in the ica.The goal was to crack an opening the 8x40 precise stent strut.An angiogram was taken and it looked to have an opening to be able to deliver a new 8x30 precise stent in the cca/ica.The stent was successfully deployed and was post dilated with the 5x20 aviator balloon.Devices removed and no closure was used.After the case, the physicians believed that the vessels were perforated or gone subintimal.They discussed the case and could not believe that the angioguard had perforated or gone subintimal.There was no resistance when they initially tracked the angioguard up what they had thought was the ica.With further review of the films, they noticed that there was a small side branch 5mm beyond the bifurcation in the ica (just below the lesion) that ran parallel with ica.In the road map view that the operators were looking at and working with, it looked as if they were tracking up the ica there fore they deployed the angioguard and stent in the side branch.No films have been acquired other than 2 still pictures of the discreet side branch that was the culprit.The product remains implanted and is thus not available for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Hemiplegia is a known potential adverse events associated with carotid stenting.Hemiparesis is weakness on one side of the body.It is less severe than hemiplegia ¿ the total paralysis of the arm, leg, and trunk on one side of the body.Thus, the patient can move the impaired side of their body, but with reduced muscular strength.People with hemiparesis often have difficulties maintaining their balance due to limb weaknesses leading to an inability to properly shift body weight.This makes performing everyday activities such as dressing, eating, grabbing objects, or using the bathroom more difficult.Hemiparesis with origin in the lower section of the brain creates a condition known as ataxia, a loss of both gross and fine motor skills, often manifesting as staggering and stumbling.Pure motor hemiparesis, a form of hemiparesis characterized by sided weakness in the leg, arm, and face, is the most commonly diagnosed form of hemiparesis.Review of the available information suggests that patient factors and procedural may have contributed to the event.There is no evidence to suggest that the event is related to the design or manufacturing process of the device and therefore no corrective actions are required at this time.It was indicated that the device complication of the stent and angioguard being deployed in the side branch was not associated with any device deficiencies.Neither the dhr nor the information available for review indicate that there is a design or manufacturing related issue, therefore, no corrective actions are required.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 1016427-2014-00078 and 9616099-2014-00471.

• 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: 3936796
• MDR Text Key: 4535099
• Report Number: 9616099-2014-00471
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 15935231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Treatment: GLIDE WIRE5X20 AVIATOR BALLOON
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR