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

Catalog Number PC0830RXC

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

Patient Problems Embolism (1829); Low Blood Pressure/ Hypotension (1914); Transient Ischemic Attack (2109); Vascular System (Circulation), Impaired (2572); Vascular Dissection (3160)

Event Date 12/13/2013

Event Type  Injury  

Event Description

As reported by the (b)(4) study the patient experienced a neurological event/tia the same day as the index procedure and also the following day.The patient is a (b)(6) male.The target lesion location was the proximal left internal carotid artery.The vessel was described as moderately calcified and moderately tortuous.The rate of stenosis was 85%.The length of the lesion was 30mm.An angioguard (701814rmc / lot 70713522) embolic protection device was advanced and positioned distal to the lesion.The lesion was pre-dilated and a precise (pc0830rxc/ lot 15782016) stent and an atrium icast stent were deployed in the lesion.There was potentially a dissection or protrusion of plaque inside the precise after post dilation so a covered stent was added, overlapping at the distal end of the precise.When the aviator 5x20 balloon was inflated the patient had approximately twenty seconds of sinus pause and seizure like activity secondary to lack of blood flow/hypotension caused by the pause.When he regained a regular rhythm that is when the aphasia and right sided weakness was noted.The only treatment was iv solu-cortef.The patient began showing improvements after two to three minutes and all symptoms were gone in less than an hour.The patient was diagnosed with a transient ischemic attack.The angioguard was removed from the vessel and upon inspection it was noticed that there was debris found in the filter basket.The event was evaluated and determined to be unrelated to the cordis product, but related to the index procedure.

Manufacturer Narrative

The next day the patient suffered a similar adverse event described as aphasia and reflex change.There was also right hemiparesis and right hemineglect.These symptoms also lasted less than 24 hours.The patient was again diagnosed with a tia.This event was determined to be unrelated to the index procedure and unrelated to the cordis product.These symptoms resolved on their own.The patient was discharged four days post procedure with a nih stroke score of 0.Aspirin and clopidogrel were prescribed at discharge.Currently the patient has intermittent short term memory issues, but according to the patient¿s daughter he was having some ¿sundowner¿s¿ type symptoms even prior to intervention.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 9616099-2014-00027, 1016427-2014-00005, and 9616099-2014-00028.

Manufacturer Narrative

Additional information received from the contact at the account states that the patient suffered bradycardia and seizure like activity with the inflation of the post dilatation balloon.Atropine was given.There was slow flow in the vessel post dilatation so the filter was quickly retrieved with the thought that the filter was ¿full¿.Once the filter was removed it appeared there was a dissection and possible thrombus.The aspiration catheter was used and then a covered stent was placed over the area that appeared to have the dissection.At the time the ½ amp of atropine was given his heart rate was actually in the 40¿s contributing to his hypotension.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 1016427-2014-00005 and 9616099-2014-00028.

Manufacturer Narrative

Adjudication minutes review.The adjudication minutes received (b)(4) 2014 agree with the previous diagnosis of a transient ischemic attack occurring the day after stent placement.However, it was originally reported that the patient had suffered a transient ischemic attack during post dilation of a non study stent which was placed to treat residual stenosis (or possible dissection).The adjudication minutes agree that this event was a cerebral vascular accident (ischemic/ embolic) stroke.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 9616099-2014-00027, 1016427-2014-00005, and 9616099-2014-00028.

Manufacturer Narrative

As reported by the sapphire study the patient experienced a neurological event/tia the same day as the index procedure and also the following day.The patient is an (b)(6) male.The target lesion location was the proximal left internal carotid artery.The vessel was described as moderately calcified and moderately tortuous.The rate of stenosis was 85%.The length of the lesion was 30mm.An angioguard (701814rmc / lot 70713522) embolic protection device was advanced and positioned distal to the lesion.The lesion was pre-dilated and a precise (pc0830rxc/ lot 15782016) stent and an atrium icast stent were deployed in the lesion.There was potentially a dissection or protrusion of plaque inside the precise after post dilation so a covered stent was added, overlapping at the distal end of the precise.Additional information was received from the contact at the account stating that the patient suffered bradycardia and seizure like activity with the inflation of the post dilatation balloon.Atropine was given.There was also slow flow in the vessel post dilatation, so the filter was quickly retrieved with the thought that the filter was ¿full¿.Once the filter was removed it appeared there was a dissection and possible thrombus.The aspiration catheter was used and then a covered stent was placed over the area that appeared to have the dissection.At the time the ½ amp of atropine was given his heart rate was actually in the 40¿s contributing to his hypotension.The next day the patient suffered a similar adverse event described as aphasia and reflex change.There was also right hemiparesis and right hemineglect.These symptoms also lasted less than 24 hours.The patient was again diagnosed with a tia.This event was determined to be unrelated to the index procedure and unrelated to the cordis product.These symptoms resolved on their own.The patient was discharged four days post procedure with a nih stroke score of 0.Aspirin and clopidogrel were prescribed at discharge.Currently the patient has intermittent short term memory issues, but according to the patient¿s daughter he was having some ¿sundowner¿s¿ type symptoms even prior to intervention.The product was not returned for evaluation and testing.A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.Hypotension, hypoperfusion 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.Dissection is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.The physical manipulation inherent in the stent implantation procedure intentionally disrupts the vessel plaque and intima in an effort to reconstruct viable patent vasculature and treat the atherosclerotic disease process.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.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.Thrombosis can cause serious post-procedural complications of stent occlusion or distal embolization, resulting in acute cerebral infarction.Review of the available information suggests that aside from inherent risk of procedure vessel characteristics may have contributed to the event.There is no evidence to suggest that this event is manufacturing or design related.No corrective or preventive actions will be taken at this time.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 9616099-2014-00027, 1016427-2014-00005, and 9616099-2014-00028.

Manufacturer Narrative

The adjudication minutes received agree with the previous diagnosis of a transient ischemic attack occurring the day after stent placement.However, it was originally reported that the patient had suffered a transient ischemic attack during post dilation of a non study stent which was placed to treat residual stenosis (or possible dissection).The adjudication minutes agree that this event was a cerebral vascular accident (ischemic/ embolic) stroke.The patient is an (b)(6) male.The target lesion location was the proximal left internal carotid artery.The vessel was described as moderately calcified and moderately tortuous.The rate of stenosis was 85%.The length of the lesion was 30mm.An angioguard (701814rmc / lot 70713522) embolic protection device was advanced and positioned distal to the lesion.The lesion was pre-dilated and a precise (pc0830rxc/ lot 15782016) stent and an atrium icast stent were deployed in the lesion.There was potentially a dissection or protrusion of plaque inside the precise after post dilation so a covered stent was added, overlapping at the distal end of the precise.Additional information was received from the contact at the account stating that the patient suffered bradycardia and seizure like activity with the inflation of the post dilatation balloon.Atropine was given.There was also slow flow in the vessel post dilatation, so the filter was quickly retrieved with the thought that the filter was ¿full¿.Once the filter was removed it appeared there was a dissection and possible thrombus.The aspiration catheter was used and then a covered stent was placed over the area that appeared to have the dissection.At the time the ½ amp of atropine was given his heart rate was actually in the 40¿s contributing to his hypotension.The next day the patient suffered a similar adverse event described as aphasia and reflex change.There was also right hemiparesis and right hemineglect.These symptoms also lasted less than 24 hours.The patient was again diagnosed with a tia.This event was determined to be unrelated to the index procedure and unrelated to the cordis product.These symptoms resolved on their own.The patient was discharged four days post procedure with a nih stroke score of 0.Aspirin and clopidogrel were prescribed at discharge.Currently the patient has intermittent short term memory issues, but according to the patient¿s daughter he was having some ¿sundowner¿s¿ type symptoms even prior to intervention.The product was not returned for evaluation and testing.A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.Hypotension, hypoperfusion and the resultant stroke are well-known potential adverse events associated with the carotid stent implantation procedure.Stroke is associated with a stoppage or slowing of blood flow to the cerebral arteries.The physical manipulation of the carotid arteries produces the risk of dislodgement of debris that may travel upstream to the cerebral arteries potentially disrupting perfusion.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.Dissection is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of intimal dissection during interventional procedures.The physical manipulation inherent in the stent implantation procedure intentionally disrupts the vessel plaque and intima in an effort to reconstruct viable patent vasculature and treat the atherosclerotic disease process.There is no evidence to suggest there were any manufacturing issues that contributed to the reported event.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.Thrombosis can cause serious post-procedural complications of stent occlusion or distal embolization, resulting in acute cerebral infarction.Review of the available information suggests that aside from inherent risk of procedure vessel characteristics may have contributed to the event.There is no evidence to suggest that this event is manufacturing or design related.No corrective or preventive actions will be taken at this time.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 9616099-2014-00027, 1016427-2014-00005, and 9616099-2014-00028.

• 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: 3567058
• MDR Text Key: 4073742
• Report Number: 9616099-2014-00027
• 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,Followup,Followup,Followup
• Report Date: 12/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 15782016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• 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: AVIATOR BALLOON
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 59