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

Catalog Number PC0940RXC

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

Patient Problem Transient Ischemic Attack (2109)

Event Date 12/16/2013

Event Type  Injury  

Event Description

As reported by the sapphire registry, the patient experienced a transient ischemic attack (tia) approximately four days post index procedure.The patient had left visual field loss, left hemiparesis, left hemineglect, aphasia, and reflex change.No treatment was provided to the patient for the tia.Duration was <24 hours.Onset was gradual (last seen 'normal'' day of index procedure).Deficits: the wife reported that she felt patient had 'weakness in his left arm' and 'she could not move him or transport him or ambulate him.' recovery was partial with minor residual.The patient was hospitalized one day and was discharged to a skilled nursing facility where follow-up was performed.He was discharged from hospital with 'generalized weakness'.Pre-procedure nih stroke scale score was 1 and rankin score was 4.Carotid artery stenting (cas) was performed on an 90% occluded lesion in the ostial right internal carotid artery of 26mm in length in a 9.0mm vessel diameter with moderate calcification.The arch i lesion had no documented tortuosity.A 5mm basket angioguard protection device was deployed past the lesion and the lesion was predilated.A 9x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 24%.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient was discharged two days following the index procedure.Approximately four days post index procedure, the patient had a tia.As per the investigator, the event was unrelated to the cordis device or index procedure.The patient had their 30-day follow-up approximately one month after the index procedure.Nih stroke scale score was 8 and rankin score was 5.

Manufacturer Narrative

The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.Concomitant medications: bivalirudin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel; angioguard rx catalog number 601847rmc, lot number 35220012.

Manufacturer Narrative

Complaint conclusion: as reported by the (b)(4) registry, the patient experienced a cerebrovascular accident (cva) approximately four days post index procedure.The event was determined to be procedure-related and device-related.The patient had left visual field loss, left hemiparesis, left hemineglect, aphasia, and reflex change : the wife reported that she felt patient had 'weakness in his left arm'' and 'she could not move him or transport him or ambulate him.' recovery was partial with minor residual.The patient was hospitalized one day and was discharged to a skilled nursing facility where follow-up was performed.He was discharged from hospital with 'generalized weakness'.Pre-procedure the nih stroke scale score was 1 due to minor facial droop, and the rankin stroke scale score was 4.Carotid artery stenting (cas) was performed on a 90% occluded lesion in the ostial right internal carotid artery of 26mm in length in a 9.0mm vessel diameter with moderate calcification.The arch i lesion had no documented tortuosity.A 5mm basket angioguard protection device was deployed past the lesion and the lesion was pre-dilated.A 9x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 24%.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.Post-procedure, the nih stroke scale score was 2 due to drowsiness and only one loc question answered correctly.The rankin stroke scale score was 4.The following day the nih stroke scale score was 0 and the rankin stroke scale score was 4.The patient was discharged two days following the index procedure on asa and clopidogrel.As per admission report, four days post index procedure, the patient the patient presented with the chief complaint of weakness in his left arm.Neurological event form reported that the patient developed aphasia, reflex change, left visual field loss, left hemineglect, and left hemiparesis or hemiplegia.The nih/mend (miami emergent neurologic deficit) stroke scale score was 7 due to partial hemianopia (left visual field), minor facial paralysis (left facial droop), left arm drift, left leg drift, left-sided ataxia grade 2 (cannot perform either task), and mild to moderate dysarthria.A head ct scan on day of admission revealed no acute abnormalities, noting a focal area of encephalomalacia in the right periventricular white matter adjacent to the tail of caudate.An mri was not performed due to a recently placed stent.The mend stroke scale score was assessed every three hours and was 7 on day 5 and 6 post index procedure.Six days after stent placement, the mend stroke scale score was 6 due to loc question ¿abnormal (oriented only to person), left visual field loss, left facial droop, left arm drift, left leg drift, and left- sided ataxia and remained 6 until 7 days post index procedure.7 days after stent placement, the mend stroke scale score was 4 due to left facial droop, left arm drift, left leg drift, and left-sided ataxia.Neurology consultation report on day 6 post procedure noted that the patient had initially significant weakness on the left side.At the time of consultation, he had minimal, mostly generalized weakness with no new focal weaknesses.It further noted that per information obtained from chart and medical staff, the patient had a history of dementia with mild confusion.General appearance: lying in the bed, mostly stable, except for significant confusion and lethargy.Further neurological examination noted mental exam confusion, cranial nerves stable, motor moves - bilaterally, sensory exam showed mild neuropathy.Impression: possibility of small stroke.Bilateral carotid doppler ultrasound 7 days post index procedure revealed no hemodynamically significant stenoses.The patient was discharged on this day with diagnosis of tia according to the site.Physical examination at discharge reported the patient had his usual confusion and was able to move his left upper extremity.At 30-day follow-up visit, approximately one month post index procedure, the nih stroke scale score was 8 due to drowsiness, none of loc questions answered, left arm drift, left leg drift, ataxia grade 1, and mild to moderate aphasia.The rankin stroke scale score was 5.The (b)(6) male patient has a medical history of stroke, coronary artery disease, myocardial infarction, coronary percutaneous revascularization, hypertension , and high-risk criteria: age > 75.The complaint product was not returned for analysis as it remains implanted.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15621764 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Cerebrovascular accident (cva) 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.Eighty percent 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 event.Therefore, no corrective action will be taken.

Manufacturer Narrative

Complaint conclusion: as reported by the sapphire registry, the patient experienced a transient ischemic attack (tia) approximately four days post index procedure.The patient had left visual field loss, left hemiparesis, left hemineglect, aphasia, and reflex change.No treatment was provided to the patient for the tia.Duration was <24 hours.Onset was gradual (last seen 'normal'' day of index procedure).Deficits: the wife reported that she felt patient had 'weakness in his left arm'' and 'she could not move him or transport him or ambulate him.' recovery was partial with minor residual.The patient was hospitalized one day and was discharged to a skilled nursing facility where follow-up was performed.He was discharged from hospital with generalized weakness.Pre-procedure nih stroke scale score was 1 and rankin score was 4.Carotid artery stenting (cas) was performed on a 90% occluded lesion in the ostial right internal carotid artery of 26mm in length in a 9.0mm vessel diameter with moderate calcification.The arch i lesion had no documented tortuosity.A 5mm basket angioguard protection device was deployed past the lesion and the lesion was predilated.A 9x40mm precise pro rx stent was successfully deployed at the target lesion.The residual diameter stenosis measured 24%.There was no documented presence of air bubbles.The patient was neurologically intact upon leaving the angiography suite.The patient was discharged two days following the index procedure.Approximately four days post index procedure, the patient had a tia.As per the investigator, the event was unrelated to the cordis device or index procedure.The patient had their 30-day follow-up approximately one month after the index procedure.Nih stroke scale score was 8 and rankin score was 5.The (b)(6) male patient has a medical history of stroke, coronary artery disease, myocardial infarction, coronary percutaneous revascularization, and hypertension.High-risk criteria include age > 75.The product remains implanted in the patient and are thus unavailable for evaluation.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Tia is a well-known potential adverse event associated with the carotid stent implantation procedure and is listed in the ifu as such.Tia is often associated with a temporary 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 collect in the embolic protection device or flow downstream potentially disrupting perfusion both during and after carotid stent implantation.By definition (mayoclinic.Org), the symptoms of a tia may last up to 24 hours, but they often last only a few minutes.Tia occurs when the blood supply to part of the brain is briefly interrupted.Tia symptoms are similar to those of stroke but do not last as long.Most symptoms of a tia disappear within an hour.There is no evidence that manufacturing issues contributed to the event.Review of the information suggests that patient (extensive medical history), vessel and procedural factors may have contributed to the reported event.

Manufacturer Narrative

Adjudication minutes were received and additional information was provided.The event was adjucated as a cva.(b)(4).The event was determined to be procedure-related and device-related.Pre-procedure on (b)(6) 2013 the nih stroke scale score was 1 due to minor facial droop, and the rankin stroke scale score was 4.The site reported no post-procedure maes.On (b)(6) 2013 at 14:00 the nih stroke scale score was 2 due to drowsiness and only one loc question answered correctly.The rankin stroke scale score was 4.On (b)(6) 2013 the nih stroke scale score was 0 and the rankin stroke scale score was 4.The patient was discharged on (b)(6) 2013 on asa and clopidogrel.Per admission report, on (b)(6) 2013 the patient presented with the chief complaint of weakness in his left arm.Neurological event form reported that on (b)(6) 2013 the patient developed aphasia, reflex change, left visual field loss, left hemineglect, and left hemiparesis or hemiplegia.On (b)(6) 2013 at 22:00 the nih/mend (miami emergent neurologic deficit) stroke scale score was 7 due to partial hemianopia (left visual field), minor facial paralysis (left facial droop), left arm drift, left leg drift, left-sided ataxia grade 2 (cannot perform either task), and mild to moderate dysarthria.A head ct scan on (b)(6) 2013 revealed no acute abnormalities, noting a focal area of encephalomalacia in the right periventricular white matter adjacent to the tail of caudate.An mri was not performed due to a recently placed stent.The mend stroke scale score was assessed every three hours and was 7 on (b)(6) 2013 up to 16:24.On (b)(6) 2013 at 19:48, the mend stroke scale score was 6 due to loc question ¿abnormal (oriented only to person), left visual field loss, left facial droop, left arm drift, left leg drift, and left- sided ataxia and remained 6 on (b)(6) 2013 at 23:42 and on (b)(6) 2013 at 03:51.On (b)(6) 2013 at 08:44, at 11:50, and at 14:34, the mend stroke scale score was 4 due to left facial droop, left arm drift, left leg drift, and left-sided ataxia.Neurology consultation report on (b)(6) 2013 noted that the patient had initially significant weakness on the left side.At the time of consultation, he had minimal, mostly generalized weakness with no new focal weaknesses.It further noted that per information obtained from chart and medical staff, the patient had a history of dementia with mild confusion.General appearance: lying in the bed, mostly stable, except for significant confusion and lethargy.Further neurological examination noted mental exam confusion, cranial nerves stable, motor moves - bilaterally, sensory exam showed mild neuropathy.Impression: possibility of small stroke.Bilateral carotid doppler ultrasound (b)(6) 2013 revealed no hemodynamically significant stenoses.The patient was discharged on (b)(6) 2013 with diagnosis of tia.Physical examination at discharge reported the patient had his usual confusion and was able to move his left upper extremity.On (b)(6) 2014 at 30-day follow-up visit, the nih stroke scale score was 8 due to drowsiness, none of loc questions answered, left arm drift, left leg drift, ataxia grade 1, and mild to moderate aphasia.The rankin stroke scale score was 5.Additional information is pending and will be submitted within 30 days upon receipt.

• 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: 3601451
• MDR Text Key: 4094704
• Report Number: 9616099-2014-00064
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 15621764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 85 YR
• Patient Weight: 88