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

Catalog Number PC0740RXC

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

Patient Problems Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Vascular System (Circulation), Impaired (2572)

Event Date 02/18/2014

Event Type  Injury  

Event Description

The report received from the (b)(4) study indicated that the patient had a precise 7 x 40 stent successfully implanted in the distal left common carotid artery during the study index procedure.A 5 mm.Angioguard was used.The residual stenosis post-procedure was 0%.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.Post-procedure/the same day, the patient experienced an adverse event (ae) of cerebral hyperperfusion.The onset of the event was sudden.The event was characterized by reflex change.The event was reported to be unrelated to a cordis product, or the study index procedure.No emergency cea surgery was performed.The duration of the event was greater than twenty-four hours.The patient recovered in full with no residual deficit.The patient was discharged four days after the procedure.Additional information has been requested.

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

After review, it was noted that the alert date of the initial mdr report should have been 2/28/2014.Complaint conclusion: the report received from the sapphire study indicated that the patient had a precise 7 x 40 stent successfully implanted in the distal left common carotid artery during the study index procedure.A 5 mm.Angioguard was used.The residual stenosis post-procedure was 0%.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.Post-procedure/the same day, the patient experienced sudden onset of cerebral hyperperfusion characterized by reflex change.The patient also experienced hypotension that was treated by administration of dopamine.The event was reported to be unrelated to a cordis product, or the study index procedure.No emergency cea surgery was performed.The duration of the event was greater than twenty-four hours.The patient recovered in full with no residual deficit.The patient was discharged four days after the procedure.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 15916583 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Hyperperfusion syndrome is a known potential adverse event associated with carotid stent implantation and is listed in the ifu as such.Numerous reports have documented the risk of hyperperfusion syndrome after carotid endarterectomy, carotid angioplasty and intracranial angioplasty.Evidence from observational studies 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 an ipsilateral peak middle cerebral artery flow velocity in addition to pre- and postoperative hypertension.Review of the information suggests that vessel and patient factors may have contributed to the hyperperfusion syndrome.There is no evidence of manufacturing or design issues that contributed to the event.No corrective action is required at this time.Review of the information suggests that vessel and patient factors may have contributed to the reported event.The product was not returned for analysis.Based on the lack of information and the inability to assign or determine a root cause no corrective actions will be taken at this time.

Manufacturer Narrative

Additional information was received.The adjudication minutes were received and reviewed.The committee indicated that: cva - major, ipsilateral, ischemic/embolic-procedure-related/device-related-agree.The patient underwent the index procedure with delivery of the angioguard rx ecgw, pre-stent balloon angioplasty and placement of one precise pro stent in the left mid cca.Upon retrieval of the angioguard rx ecgw, site reported ¿unknown¿ whether debris was found in the filter.The patient tolerated the procedure well.During the procedure, according to neurology consultation note, the patient was noted to have fluctuation of blood pressure ranging from 70 to 170 systolic, but patient had no deficits during the case.The site reported a 0% final residual in-lesion stenosis.Right after the procedure, she noted right upper extremity weakness, and a stroke page was activated.On initial assessment, she had a nih stroke scale score of 5: 4 points for right upper extremity weakness and 1 for right lower extremity drift, as per neurology consultation report.After the case the patient was again hypotensive and was administered dopamine and iv fluids.Initially tpa treatment was considered, but as nih decreased from 5 to 2, tpa treatment was reconsidered.A bran ct scan for right upper extremity weakness revealed no ct evidence of an acute intracranial process; there was a remote small focal infarction in the right frontal white matter and intracranial calcific atherosclerosis noted.Per neurology progress notes, the patient¿s right upper extremity strength was 4/5, and the rest was 5/5.There were no other focal neurological deficits noted.Impression: tia/stroke; rue weakness after left cca stent placement.Mri and mra recommended per stroke protocol.The patient was admitted to icu with permissive hypertension with systolic between 160 and 180 and if systolic <180, it is not to be corrected.Per entry in the edc discharge form, the nih stroke scale score was 0 and the rankin stroke scale score was not evaluated.A brain mri, compared to the previous ct scan, revealed multiple foci of cortical diffusion involving the left precentral gyrus, left frontal lobe, left parietal and left occipital lobes.There was no hemorrhagic transformation.Another brain mra revealed irregularity of flow related signal involving the petrous, cavernous, and clinoid segment of the left ica when compared to the right; milder attenuation of flow related enhancement involving the m1 and proximal m2 segments of the left mca; slight fullness of the flow related enhancement involving the anterior communicating artery, with aneurysm not definitely excluded; and tandem attenuation of flow related enhancement involving the v4 segment of the dominant left vertebral artery, the left vertebrobasilar junction, and proximal basilar artery.Per pre-discharge progress notes regarding tia/stroke: rue weakness after l cca stent placement, patient back to normal; suspect to be due to hyperperfusion syndrome.The site reported event of cerebral hyperperfusion syndrome on (b)(6) 2014.The patient was discharged on asa and clopidogrel.Based on the additional information received, the adverse event (ae) code of cerebral hyperperfusion is being deleted and the ae code of cerebrovascular accident (cva) is being added.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information received indicated that the patient experienced hypotension that was treated by administration of dopamine.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

Cc updated to reflect the adjudication minutes received.The adjudication minutes received indicated that the patient experienced a cerebrovascular accident (cva)/stroke which was ischemic/embolic in nature.A brain mri, compared to the previous ct scan, revealed multiple foci of cortical diffusion involving the left precentral gyrus, left frontal lobe, left parietal and left occipital lobes.There was no hemorrhagic transformation.A brain mra revealed irregularity of flow related signal involving the petrous, cavernous, and clinoid segment of the left ica when compared to the right; milder attenuation of flow related enhancement involving the m1 and proximal m2 segments of the left mca; slight fullness of the flow related enhancement involving the anterior communicating artery, with aneurysm not definitely excluded; and tandem attenuation of flow related enhancement involving the v4 segment of the dominant left vertebral artery, the left vertebrobasilar junction, and proximal basilar artery.The patient had a precise 7 x 40 stent successfully implanted in the distal left common carotid artery during the study index procedure.A 5 mm.Angioguard was used.The residual stenosis post-procedure was 0%.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.Post-procedure/the same day, the patient experienced sudden onset of cerebral hyperperfusion characterized by reflex change.The patient also experienced hypotension that was treated by administration of dopamine.The event was reported to be unrelated to a cordis product, or the study index procedure.No emergency cea surgery was performed.The duration of the event was greater than twenty-four hours.The patient recovered in full with no residual deficit.The patient was discharged four days after the procedure.The product was not returned for inspection.Review of lot 15916583 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.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.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.

• 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: 3676892
• MDR Text Key: 4289779
• Report Number: 9616099-2014-00184
• 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,Followup,Followup,Followup
• Report Date: 02/18/2014

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 Date: 05/31/2015
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 15916583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/25/2014; 05/22/2014; 06/05/2014; 06/10/2014
• 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): Life Threatening
• Patient Age: 66 YR
• Patient Weight: 65