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U.S. Department of Health and Human Services

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

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CORDIS DE MEXICO PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM) Back to Search Results
Catalog Number PC1040RXC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 11/15/2013
Event Type  Injury  
Event Description
As reported by (b)(6), a patient was diagnosed with a tia two days after being discharged from hospital following a carotid stenting (cas) procedure with a 10x40mm precise pro rx stent.Preliminary cec notice adjudicated stroke as a secondary event, occuring one day after the index procedure.Cec minutes received indicate the symptoms began 3 days prior and that it was device related.The patient was asymptomatic at study inclusion.Baseline nih stroke scale score was 0 and the rankin score was 2.Cas was performed on an 85% occluded lesion in the proximal left internal carotid artery of 15mm in length in a 6.0mm vessel diameter with mild vessel tortuosity.The arch ii lesion was eccentric, ulcerated and mildly calcified.A 7mm medium support angioguard embolic protection device was deployed past the lesion and a 10x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 10%.There was no documented presence of air bubbles.The angioguard was successfully removed and there was no debris found in the basket.The patient was neurologically intact upon leaving the angio suite.The patient was discharged on the following day without any adverse events.Nih and rankin scores were unchanged from the baseline scores.According to the study, 2 days later, the patient had gradual onset of unspecified symptoms and deficits that were diagnosed as a tia.The symptoms were reported to have fully resolved.Emergency carotid endarectomy was not required.Cec minutes indicate two days after discharge, the patient presented to the emergency department with complaint of right arm weakness.He reported that when trying to sign his discharge papers, he noticed difficulty coordinating his right arm and hand.He said he could not control it.Over the past three days he had poor coordination with the right arm and hand, and intermittent weakness.He had difficulties holding onto objects.
 
Manufacturer Narrative
Event description continued: with his right hand, ¿it does not do what i want it to do¿, and he had been bumping his hand on things.He did not notice any symptoms in his right leg stump.Neurological examination in the emergency department revealed no focal deficits at that time.His hands grasp was equal.Carotid ultrasound demonstrated a patent left carotid stent and no obstructive lesions in the intracranial carotid system.A brain ct scan without contrast, with no previous study to compare, revealed chronic atrophy and chronic white matter ischemic changes, noting that there was some asymmetry with slightly more prominent hypodensities on the left (in the posterior left parietal lobe that may represent more acute ischemic change, which is unclear without prior exams for comparison), suggesting ischemia on the left of unclear chronicity.There was no hemorrhage.Emergency room medical decision-making note reported: carotid dopplers show patent flow; ct of the brain showed small possible ischemic areas in the left parietal region.Neurologist on call was consulted.The patient was already on asa and clopidogrel.Neurologist did not feel that the patient required admission.His neurological exam was intact.Echocardiography was planned in future.The patient was discharged home in stable condition.The site reported sudden onset of neurological deficits on (b)(6) 2013 that lasted greater than 24 hours and fully resolved, reporting a tia.It was classified by the cec as cva, minor, ipsilateral ischemic/embolic.Concomitant medications: bivalrudin in was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.As reported by (b)(6), a (b)(6) male patient was diagnosed with a tia two days after being discharged from hospital following a carotid stenting (cas) procedure with a 10x40mm precise pro rx stent.Preliminary cec notice adjudicated stroke as a secondary event, occurring one day after the index procedure.Cec minutes received indicate the symptoms began 3 days prior and that it was device related.The patient was asymptomatic at study inclusion.Baseline nih stroke scale score was 0 and the rankin score was 2.Cas was performed on an 85% occluded lesion in the proximal left internal carotid artery of 15mm in length in a 6.0mm vessel diameter with mild vessel tortuosity.The arch ii lesion was eccentric, ulcerated and mildly calcified.A 7mm medium support angioguard embolic protection device was deployed past the lesion and a 10x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 10%.There was no documented presence of air bubbles.The angioguard was successfully removed and there was no debris found in the basket.The patient was neurologically intact upon leaving the angio suite.The patient was discharged on the following day without any adverse events.Nih and rankin scores were unchanged from the baseline scores.According to the study, 2 days later, the patient had gradual onset of unspecified symptoms and deficits that were diagnosed as a tia.The symptoms were reported to have fully resolved.Emergency carotid endarectomy was not required.Cec minutes indicate two days after discharge, the patient presented to the emergency department with complaint of right arm weakness.He reported that when trying to sign his discharge papers, he noticed difficulty coordinating his right arm and hand.He said he could not control it.Over the past three days he had poor coordination with the right arm and hand, and intermittent weakness.He had difficulties holding onto objects with his right hand, ¿it does not do what i want it to do¿, and he had been bumping his hand on things.He did not notice any symptoms in his right leg stump.Neurological examination in the emergency department revealed no focal deficits at that time.His hands grasp was equal.Carotid ultrasound demonstrated a patent left carotid stent and no obstructive lesions in the intracranial carotid system.A brain ct scan without contrast, with no previous study to compare, revealed chronic atrophy and chronic white matter ischemic changes, noting that there was some asymmetry with slightly more prominent hypodensities on the left (in the posterior left parietal lobe that may represent more acute ischemic change, which is unclear without prior exams for comparison), suggesting ischemia on the left of unclear chronicity.There was no hemorrhage.Emergency room medical decision-making note reported: carotid dopplers show patent flow; ct of the brain showed small possible ischemic areas in the left parietal region.Neurologist on call was consulted.The patient was already on asa and clopidogrel.Neurologist did not feel that the patient required admission.His neurological exam was intact.Echocardiography was planned in future.The patient was discharged home in stable condition.The site reported sudden onset of neurological deficits on (b)(6) 2013 that lasted greater than 24 hours and fully resolved, reporting a tia.It was classified by the cec as cva, minor, ipsilateral ischemic/embolic.Medical history includes renal insufficiency, history of smoking (>5packs of cigarettes), diabetes mellitus and coronary artery disease.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.Cerebrovascular accident is a known potential risk associated with implanting a stent in a carotid artery and is listed in the ifu as such.It can be defined as a cerebrovascular disorder caused by deprivation of blood flow to an area of the brain, generally as a result of thrombosis, embolism, or reduced blood pressure.The act of stent expansion or post-dilatation, to optimally oppose a carotid stent to the vessel wall, temporarily obstructs blood flow to the cerebral arteries (ischemic process).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.This act, inherent to the procedure may have contributed to the reported event.A blood vessel that is not blocked, but is extremely narrowed, can also cause an ischemic stroke.The blocked or narrowed arteries deprive brain cells of oxygen and nutrients, leading to nerve cell death.80% of all strokes are ischemic.During ischemic stroke, diminished blood flow initiates a series of events (called ischemic cascade) that may result in additional, delayed damage to brain cells.Early medical intervention can halt this process and reduce the risk for irreversible complications.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.
 
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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
aaron goodstein
miami lakes, FL 33014
63136118
MDR Report Key3843367
MDR Text Key4659171
Report Number9616099-2014-00360
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/25/2013
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 Date11/30/2013
Device Catalogue NumberPC1040RXC
Device Lot Number15529367
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/12/2014
Initial Date FDA Received06/02/2014
Date Device Manufactured02/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ANGIOGUARD RX 70184RMC
Patient Outcome(s) Other;
Patient Age75 YR
Patient Weight84
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