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

Catalog Number PC0730RXC

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

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 03/01/2014

Event Type  Injury  

Event Description

The report received from (b)(6) indicated that the patient had a precise 7 x 30 stent successfully implanted in the ostial left internal carotid artery (lica) during the study index procedure.A 5 mm angioguard was used.There were no reported procedural complications, device deviations or adverse events reported during the procedure.The patient had no neurological deficit upon leaving the angiography suite post-procedure.The patient was discharged three days after the procedure with a nih stroke scale score of two (2) and stroke scale score of zero (0).No acute infarct was noted on the mri the day after re-admission to the hospital or the mri done three days later.The mri report done the day after admission indicated that the stent was in the right internal carotid artery.The nihss of two (2) was documented for a left facial droop and left arm drift as per the neurovascular physician with a modified rankin score of zero.The baseline nih stroke scale and stroke scale scores were zero (0).The ostial lica target lesion was reported to be: a 90% stenosis, 15 mm.In length, 6 mm.Reference diameter, mildly calcified, and mildly tortuous.The lesion was pre-dilated.The residual stenosis was 50%.Five days after discharge the patient experienced a neurological adverse event (ae) of cerebral hyperperfusion syndrome (which was changed from transient ischemic attack/tia).The onset of the event was sudden.The neurological deficit options were reported as ¿other¿.The event was characterized by left hemiparesis.

Manufacturer Narrative

The event was reported to be not related to a cordis product of the index procedure.The treatment of the cerebral hyperperfusion included: elevated head of bed (hob) to 30 degrees, tight systolic blood pressure (sbp) control between 90-140, dual antiplatelet agents, aggressive headache management, titrated antiepileptic agent keppra, imaging monitoring, and eeg monitoring.Her nihss three days after admission was 1.No emergency cea surgery was necessary.The event duration was less than twenty-four hours (<24 hours).The patient recovery was reported to be full/no deficit.Presence of babinski-none documented.No additional information is available.The device remains implanted in the patient and is not available for inspection.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, five days after discharge the patient experienced a neurological adverse event (ae) of cerebral hyperperfusion syndrome (which was changed from transient ischemic attack/tia).The onset of the event was sudden.The neurological deficit options were reported as ¿other¿.The event was characterized by left hemiparesis.No acute infarct was noted on the mri the day after re-admission to the hospital or the mri done three days later.The nihss of two (2) was documented for a left facial droop and left arm drift as per the neurovascular physician with a modified rankin score of zero.The baseline nih stroke scale and stroke scale scores were zero (0).The event was reported to be not related to a cordis product of the index procedure.The treatment of the cerebral hyperperfusion included: elevated head of bed (hob) to 30 degrees, tight systolic blood pressure (sbp) control between 90-140, dual antiplatelet agents, aggressive headache management, titrated antiepileptic agent keppra, imaging monitoring, and eeg monitoring.Her nihss three days after admission was 1.No emergency cea surgery was necessary.The event duration was less than twenty-four hours (<24 hours).The patient recovery was reported to be full/no deficit.Presence of babinski-none documented.The patient had a precise 7 x 30 stent successfully implanted in the ostial left internal carotid artery (lica) during the study index procedure.A 5 mm.Angioguard was used.The ostial lica target lesion was reported to be: a 90% stenosis, 15 mm.In length, 6 mm.Reference diameter, mildly calcified, and mildly tortuous.The lesion was pre-dilated.The residual stenosis was 50%.There were no reported procedural complications, device deviations or adverse events reported during the procedure.The patient had no neurological deficit upon leaving the angiography suite post-procedure.The patient was discharged three days after the procedure with a nih stroke scale score of two (2) and stroke scale score of zero (0).The device remains implanted in the patient and is not available for inspection.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Based on the information provided and the inability to assign or determine a root cause, no corrective actions will be taken at this time.Numerous reports have subsequently documented the risk of hyperperfusion syndrome after carotid endarterectomy, after carotid angioplasty and after intracranial angioplasty.It is a known potential adverse event associated with carotid stent implantation and is listed in the ifu as such.After revascularization that alleviates a high-grade symptomatic stenotic lesion, cerebral hyperperfusion syndrome (chs) may occur as a result of a sudden, rapid increase in cerebral blood flow excess of that required to meet metabolic demands.There are various factors implicated as playing a role in chs, such as cerebral autoregulation, hypertension, ischemia reperfusion injury, intraoperative ischemia, oxygen derived free radicals and baroreceptor dysfunction.Transient cerebral hyperemia can lead to severe unilateral headache, face and eye pain, confusion, seizures, focal neurologic deficits, and intracerebral hemorrhages.Typically, intracerebral hemorrhage develops on the third to fifth postoperative day, though there have been cases observed immediately after surgery, as well as cases developed 3 weeks after revascularization.Anticoagulation is a known risk factor for brain hemorrhage in patients with pre-existing disease.The use of tpa also puts the patient at a higher risk for experience a hemorrhagic stroke.Evidence from observational studies, in lack of randomized trials, suggests that a number of factors-all referable to hemodynamic exhaustion of the cerebral circulation-play a role, such as recent stroke, surgery for very tight internal carotid artery stenosis, concomitant contralateral tight lesion, impaired cerebrovascular reserve (cerebral hypoperfusion), and marked postoperative increase of in ipsilateral peak middle cerebral artery flow velocity in addition to pre- and postoperative hypertension.Cerebral hyperperfusion syndrome (chs) is a known potential adverse event associated with implanting carotid stents.There is no evidence to suggest that the event is related to the design or manufacturing process of the device.Review of the available information suggests that patient factors and/or vessel/lesion characteristics may have contributed to the event.No corrective or preventive action will be taken, given that; with the information provided the reported failure/event does not appear to be related to the manufacturing process.

• 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: 3698645
• MDR Text Key: 4336845
• Report Number: 9616099-2014-00215
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• 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: PC0730RXC
• Device Lot Number: 15922198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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: 5 MM ANGIOGUARD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 69