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

Catalog Number PC0830RXC

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/04/2014

Event Type  Injury  

Event Description

As reported by the (b)(4) registry a precise pro rx us carotid system was used on right ostium internal carotid artery.The information states that the day after the index procedure the patient suffered a neurological event described as behavioral change and aphasia and dysarthria.Left sided hemiparesis and hemineglect, diagnosis was an acute cerebrovascular accident (cva).Onset was unknown and recovery was full with no deficit.The patient is a (b)(6) female.The target vessel was described as moderately calcified and moderately tortuous.The lesion was eccentric with thrombus present within the lesion.An angioguard was advanced and deployed distal to the lesion.A precise stent was successfully deployed in the lesion.The stent was post-dilated with an aviator balloon to 10 atmospheres for 6 seconds.After post-dilation the patient became hypotensive and was given a bolus of neosynephrine.When the angioguard was removed and inspected there was no debris found in the filter basket.There was no thrombus at the target site after stent placement.The procedure was successfully completed.The next day the patient suffered the cva.The symptoms resolved on their own.The cva did not leave any residual effects by the end of hospitalization.The symptoms were resolved without any intervention.Nih stroke scale was 16 on the day of the event, 0 on the day after the event and 0 at discharge five days later.The patient was discharged from the hospital intact from any neurological sequelae.Delay in discharge was contributed also to other medical conditions such as hypotension, acute kidney injury, urinary tract infection and anemia.

Manufacturer Narrative

As reported by the sapphire registry a precise pro rx us carotid system was used on right ostium internal carotid artery.The information states that the day after the index procedure the patient suffered a neurological event described as behavioral change and aphasia and dysarthria.Left sided hemiparesis and hemineglect, diagnosis was an acute cerebrovascular accident (cva).Onset was unknown and recovery was full with no deficit.The patient is an (b)(6) year old female.The target vessel was described as moderately calcified and moderately tortuous.The lesion was eccentric with thrombus present within the lesion.An angioguard was advanced and deployed distal to the lesion.A precise stent was successfully deployed in the lesion.The stent was post-dilated with an aviator balloon to 10 atmospheres for 6 seconds.After post-dilation the patient became hypotensive and was given a bolus of neosynephrine.When the angioguard was removed and inspected there was no debris found in the filter basket.There was no thrombus at the target site after stent placement.The procedure was successfully completed.The next day the patient suffered the cva.The symptoms resolved on their own.The cva did not leave any residual effects by the end of hospitalization.The symptoms were resolved without any intervention.Nih stroke scale was 16 on the day of the event, 0 on the day after the event and 0 at discharge five days later.The patient was discharged from the hospital intact from any neurological sequelae.Delay in discharge was contributed also to other medical conditions such as hypotension, acute kidney injury, urinary tract infection and anemia.The product was not returned for evaluation and testing.A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.Hypotension and the resultant cerebrovascular accident (cva) are well-known potential adverse events associated with the carotid stent implantation procedure.Cva occurs when the blood supply to part of the brain is interrupted.The hemodynamic instability that occurs both during and after carotid stent implantation is influenced by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds (stent delivery system) and distal protection devices, initiating a reflex via the glossopharyngeal nerve.This results in a fall in blood pressure and bradycardia.Stent placement may promote persistent stimulation of these baro-receptors.These reactions are anticipated relatively short-term adverse events associated with the compression of the baro-receptors during balloon inflation, stent implantation and filter device manipulation.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 this event.Dhr review confirmed that the product met specifications.No corrective actions will be taken at this time.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 9616099-2014-00117, 1016427-2014-00023, and 9616099-2014-00118.

Manufacturer Narrative

The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Please note that this medwatch report represents one of three products involved with this event which is associated with mfg.Report # 9616099-2014-00117, 1016427-2014-00023, and 9616099-2014-00118.

Manufacturer Narrative

Adjudication notice received confirmed ae that was originally reported (cva).The adjudication committee agrees that the event was procedure related and device related.The adjudication revealed that a ct scan, which was read two days after being originally performed, found right mca artery subcortical infarct.There was some residual effects from the event and almost completely resolved.Follow up consultation, four days post procedure, also reported acute cerebrovascular accident with left upper extremity weakness.The site reported that the subject's only ct scan was performed the day after the procedure and no additional follow-up ct scans were done during the hospitalization.As originally reported by the sapphire registry a precise pro rx us carotid system was used on right ostium internal carotid artery.The information states that the day after the index procedure the patient suffered a neurological event described as behavioral change and aphasia and dysarthria.Left sided hemiparesis and hemineglect, diagnosis was an acute cerebrovascular accident (cva).Onset was unknown and recovery was full with no deficit.The patient is an (b)(6) female.The target vessel was described as moderately calcified and moderately tortuous.The lesion was eccnetric with thrombus present within the lesion.An angioguard was advanced and deployed distal to the lesion.A precise stent was successfully deployed in the lesion.The stent was post-dilated with an aviator balloon to 10 atmospheres for 6 seconds.After post-dilation the patient became hypotensive and was given a bolus of neosynephrine.When the angioguard was removed and inspected there was no debris found in the filter basket.There was no thrombus at the target site after stent placement.The procedure was successfully completed.The next day the patient suffered the cva.The symptoms resolved on their own.The cva did not leave any residual effects by the end of hospitalization.The symptoms were resolved without any intervention.Nih stroke scale was 16 on the day of the event, 0 on the day after the event and 0 at discharge five days later.The patient was discharged from the hospital intact from any neurological sequelae.Delay in discharge was contributed also to other medical conditions such as hypotension, acute kidney injury, urinary tract infection and anemia.The site reported that the subject's only ct scan was performed the day after the procedure and no additional follow-up ct scans were done during the hospitalization.The product was not returned for evaluation and testing.A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.Hypotension and the resultant cerebrovascular accident (cva) are well-known potential adverse events associated with the carotid stent implantation procedure.Cva occurs when the blood supply to part of the brain is interrupted.The hemodynamic instability that occurs both during and after carotid stent implantation is influenced by the baro-receptors, which are located at the carotid bifurcation.These baro-receptors are stimulated by the stretch of interventional balloons, sds (stent delivery system) and distal protection devices, initiating a reflex via the glossopharyngeal nerve.This results in a fall in blood pressure and bradycardia.Stent placement may promote persistent stimulation of these baro-receptors.These reactions are anticipated relatively short-term adverse events associated with the compression of the baro-receptors during balloon inflation, stent implantation and filter device manipulation.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 this event.Dhr review confirmed that the product met specifications.No corrective actions will be taken at this time.

• 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: 3637197
• MDR Text Key: 4178099
• Report Number: 9616099-2014-00117
• 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
• Report Date: 02/05/2014

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: 09/30/2015
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 15983748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 02/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/25/2014; 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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: ANGIOGUARD, AVIATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR