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

Catalog Number PC0740RXC

Device Problems Occlusion Within Device (1423); Defective Component (2292)

Patient Problems Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 05/19/2014

Event Type  Injury  

Manufacturer Narrative

The report received from the sales rep indicated that post deployment of a 7x40mm precise stent in the left common carotid and 10mm above the bifurcation, narrowing at the waist of the stent was seen and post-dilatation was performed with a 5x30mm aviator balloon.No further information is available at this time.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00372 and 1016427-2014-00064.

Manufacturer Narrative

Post deployment of a precise pro stent in the left common carotid artery 10mm above the bifurcation, with a 4mm medium support angioguard distal of the lesion, narrowing at the waist of the stent was seen and post-dilatation was performed with a 5x30mm aviator balloon.After the balloon was removed, there was no flow past 1/3 of the stent.A.035 straight catheter was used to extract out about 15cc¿s of blood and flow was restored.However, a spasm and narrowing was noted distal to the angioguard which was treated with nitro with some improvement but some haziness remained.The angioguard was removed and a clot was noted in the filter basket.There was still haziness after removal of the angioguard and it was thought that there was a clot distal to the angioguard which was treated with reopro.Carotid stenting was performed in an 80% occluded lesion in the left common carotid artery of 6mm in length and 3mm in length in the distal ica.The lesion was not heavily calcified and the vessel was not tortuous.It was a bovine type i arch.Pre-dilation was performed.Multiple unsuccessful attempts were made to gather additional information.There was no reported patient injury.The product was not returned for analysis.Additionally, as the sterile lot number was not available, device history record review could not be performed.It is not known what the residual stenosis was after pre-dilation or if the vessel was resistant to pta.It is not known if the narrowing was secondary to vessel characteristics, plaque formation or other etiology.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 in side of the stent around the damaged areas.Several factors, including mechanical plaque disruption, intimal injury, and stent thrombogenicity predispose the patient to thromboembolic events.Platelet adhesion, activation, and aggregation play main roles in mural thrombus formation.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.Local vasospasm can be caused by the outward radial force and axial friction of the filter¿s basket, or by the device manipulations inherent in any procedure causing endothelial irritation.A carotid vessel spasm is a brief temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow to the brain.This may lead to tia like symptoms such as muscular or neurological changes.Treatment of arterial spasms may include medications such as nitrates and calcium channel blockers.Hypoperfusion.The function of an embolic protection device is to capture debris during the carotid procedure and prevent it from embolizing downstream into the patients vasculature.If enough debris is dislodged from the arterial wall during the procedure it may fill the filter basket to the point at which it interferes with normal blood flow through the filter resulting in hypoperfusion.Normal blood flow resumes upon removal of the device or removal of the debris in the filter by means of an aspiration catheter.This is an inherent risk of the procedure and does not represent a device malfunction.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.With the information available and without return of the product for analysis or films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to the reported event.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00372 and 1016427-2014-00064.

Event Description

The report received from the sales rep indicated that post deployment of a n the left common carotid and 10mm above the bifurcation, with a 4mm medium support angioguard distal of the lesion, narrowing at the waist of the stent was seen and post-dilatation was performed with a 5x30mm aviator balloon.After the balloon was removed, there was no flow past 1/3 of the stent.A.035 straight catheter was used to extract out about 15cc¿s of blood and flow was restored.However, a spasm and narrowing was noted distal of the angioguard which was treated with nitro.There was some improvement but was there was haziness.After removal of the angioguard, there was still haziness and it was thought there was a clot distal to the angioguard.This was treated with reopro.Carotid stenting was performed in an 80% occluded lesion in the left common carotid artery of 6mm in length and 3mm in length in the distal ica.The lesion was not heavily calcified and the vessel was not tortuous.It was a bovine type i arch.A 4mm medium support angioguard was deployed past the lesion and pre-dilatation was performed with a 3x12mm boston scientific sterling balloon.A 7x40mm precise rx stent was deployed and post deployment they saw a narrowing at the waist of the stent.Post dilatation was performed with a 5x30mm aviator balloon and when the balloon was removed they saw no flow past 1/3 of the stent.A.035 straight catheter was used to draw out 15cc¿s of blood.After that they did an angiogram and there was flow through the stent and up to the angioguard.Spasm and narrowing were noted distal of the angioguard and it was treated with nitro.There was some improvement but it was hazy.At this point they thought there was a clot distal to the angioguard.The angioguard was removed there was a clot in the basket of the angioguard.There was still haziness after removal of the angioguard.The catheter was kept in and the clot was treated with.

Manufacturer Narrative

Event description continued: reopro, ½ dose intra arterially and the remainder by iv.The patient had no stroke symptoms and was taken to an icu bed with a reopro drip.During the procedure heparin was given but the dose and level of act was not available.The patient's age is in the mid to late 50's.Concomitant medications: heparin and reopro, were given during the procedure.Concomitant devices: 4mm medium support angioguard ,.035 straight catheter and 3x12mm boston scientific sterling balloon.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.This is one of two products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00372 and 1016427-2014-00064.

• 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 Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3856006
• MDR Text Key: 12083531
• Report Number: 9616099-2014-00372
• 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,Followup
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC0740RXC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 5X30MM AVIATOR BALLOON
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention