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

Catalog Number PC1030RXC

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

Patient Problem Infarction, Cerebral (1771)

Event Date 06/21/2013

Event Type  Injury  

Event Description

As reported via the sapphire registry, a patient experienced a transient ischemic attach (tia) on the same day of the carotid index procedure.Pre-procedure nih stroke scale was 1, stroke scale was 1 and the patient was symptomatic.At the time of the index procedure, angiography revealed 75% stenosis to the left proximal internal carotid artery.The lesion was described as 20mm in length, moderately calcified and arch type i.The reference vessel was 4.5 in diameter with moderate tortuosity.A 7mm angioguard was deployed successfully beyond the target lesion and the lesion was pre-dilated.A 10 x 30mm precise pro rx was implanted at the target lesion.The angioguard was retrieved successfully.There was no debris noted in the filter basket and no air bubbles were present during the procedure.There was 10% residual stenosis.The patient left the angiography suite with no neurological deficits.On the same day of the index procedure, the patient developed aphasia and dysarthria.The symptoms were sudden and were classified as a tia.The patient fully recovered with no deficit in less than 24 hours and was not medically treated.The ct without contrast performed on (b)(6) 2013 showed no acute findings.The post procedure nih stroke scale score was 0 and the stroke scale score was 0.The patient was discharged three days later due to being intubated.The patient was extremely agitated following what was thought to be a reaction to haldol.The physician felt it was in the best interest to sedate patient due to the groin access and sheath removal.Concomitant medications included clopidogrel and aspirin at pre/post procedure and at discharge.Per the investigator, the event was related to the index procedure and not related to the cordis devices.

Manufacturer Narrative

Additional information received via the study adjudications minutes, noted that the committee agreed the event of tia was related to the procedure and related to the device.Per the neurology consultation, on (b)(6) 2013, the patient was alert, being able to say some sentences spontaneously and fluently, however, he perseverated and the majority of his speech was a word salad.He could follow some simple commands but had difficulty with more complex commands.There were no focal abnormalities noted.Neurologist reported receptive and expressive aphasia with ¿no limb focality.¿ it was noted that angiographic sequence performed after the procedure revealed no evidence of proximal occlusion or thrombus.Conclusion: suspect distal mca ischemic event.The patient was not a candidate for tpa treatment and not a candidate for intervention due to peripheral nature of suspected ischemia.During removal of a sheath on (b)(6) 2013, the patient became agitated and combative with resultant respiratory failure that required sedation and intubation with endotracheal tube placement.He was extubated on (b)(6) 2013.Per progress note, he was with no residual deficits.Per progress note on (b)(6) 2013 he was alert and oriented, with minimally dysarthric speech, normal language and no focal neurological deficits.Echocardiography on 06/23/2013 reported no abnormalities.The stroke team progress note on (b)(6) 2013 reported that the patient was alert and oriented with minimally dysarthric speech and normal language.Further neurological exam showed no focal deficits.Assessment: likely a left brain tia event, status post stenting procedure.He was discharged on (b)(6) 2013.Complaint conclusion: as reported via the sapphire registry, a patient experienced a transient ischemic attach (tia) on the same day of the carotid index procedure.Pre-procedure nih stroke scale was 1, stroke scale was 1 and the patient was symptomatic.At the time of the index procedure, angiography revealed 75% stenosis to the left proximal internal carotid artery.The lesion was described as 20mm in length, moderately calcified and arch type i.The reference vessel was 4.5 in diameter with moderate tortuosity.A 7mm angioguard was deployed successfully beyond the target lesion and the lesion was pre-dilated.A 10 x 30mm precise pro rx was implanted at the target lesion.The angioguard was retrieved successfully.There was no debris noted in the filter basket and no air bubbles were present during the procedure.There was 10% residual stenosis.The patient left the angiography suite with no neurological deficits.On the same day of the index procedure, the patient developed aphasia and dysarthria.The symptoms were sudden and were classified as a tia.The patient fully recovered with no deficit in less than 24 hours and was not medically treated.The ct without contrast performed on (b)(6) 2013 showed no acute findings.The post procedure nih stroke scale score was 0 and the stroke scale score was 0.The patient was discharged three days later due to being intubated.The patient was extremely agitated following what was thought to be a reaction to haldol.The physician felt it was in the best interest to sedate patient due to the groin access and sheath removal.Concomitant medications included clopidogrel and aspirin at pre/post procedure and at discharge.Per the investigator, the event was related to the index procedure and not related to the cordis devices.Additional information received via the study adjudications minutes, noted that the committee agreed the event of tia was related to the procedure and related to the device.Per the neurology consultation, on (b)(6) 2013, the patient was alert, being able to say some sentences spontaneously and fluently, however, he perseverated and the majority of his speech was a word salad.He could follow some simple commands but had difficulty with more complex commands.There were no focal abnormalities noted.Neurologist reported receptive and expressive aphasia with ¿no limb focality.¿ it was noted that angiographic sequence performed after the procedure revealed no evidence of proximal occlusion or thrombus.Conclusion: suspect distal mca ischemic event.The patient was not a candidate for tpa treatment and not a candidate for intervention due to peripheral nature of suspected ischemia.During removal of a sheath on (b)(6) 2013, the patient became agitated and combative with resultant respiratory failure that required sedation and intubation with endotracheal tube placement.He was extubated on (b)(6) 2013.Per progress note, he was with no residual deficits.Per progress note on (b)(6) 2013 he was alert and oriented, with minimally dysarthric speech, normal language and no focal neurological deficits.Echocardiography on (b)(6) 2013 reported no abnormalities.The stroke team progress note on (b)(6) 2013 reported that the patient was alert and oriented with minimally dysarthric speech and normal language.Further neurological exam showed no focal deficits.Assessment: likely a left brain tia event, status post stenting procedure.He was discharged on (b)(6) 2013.The products remain implanted in the patient and are thus not available for evaluation.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Ischemic stroke 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.Review of the information suggests that patient, vessel and procedural factors may have contributed to the reported events.It is also possible that due to the fact that the patient was intubated, as this is a disruption of the motor function of speech.The product was not returned for analysis.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 Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3961561
• MDR Text Key: 4555252
• Report Number: 9616099-2014-00493
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: PC1030RXC
• Device Lot Number: 15601059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 83