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 Seizures (2063)

Event Date 04/15/2014

Event Type  Injury  

Event Description

As reported by (b)(6), a patient had a sudden onset of a grand mal seizure less than a month after having a precise pro rx stent implanted.The patient was admitted to the hospital and was given ativan and keppra.Patient is still in the hospital with poor prognosis.The target lesion was located in the ostium of the left internal carotid artery with a length of 30 mm and reference diameter of 8 mm.The eccentric and ulcerated lesion was severely calcified with 95% stenosis.There was no lesion thrombosis.The vessel was a type i arch vessel with none documented tortuosity.The nih score was 7 and the rankin score was 4.The patient had a prior cva, and got age incorrect, could not open/close her left hand, had complete hemianopia, had mild decrease in sensation, mild aphasia, and mild slurring of speech.Some deficits were present due to prior cva, namely the left sided weakness.The patient was symptomatic before the procedure.Approach was made with a 7 mm angioguard rx embolic protection device, which was successfully deployed past the lesion before pre-dilation was performed.Then, an 8x30 mm precise pro rx stent was successfully implanted, leaving a final stenosis rate of 20%.The angioguard was successfully retrieved and no debris was found in the basket.There was none documented presence of air bubbles and the patient did not have a neurological deficit prior to leaving the angiography suite.The patient was discharged the next day with an nih score of 7 and a rankin score of 4.No adverse event had occurred prior to discharge.Less than a month later, the patient had a sudden onset of a grand mal seizure while at home.The patient was admitted to the hospital that day and it was reported that there have been several seizures with the first occurring that day at home.The patient has been loaded on ativan and keppra.

Manufacturer Narrative

A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Event description continued: it was also reported that the patient had neurological deficits that lasted less than 24 hours; however, the deficits are currently unknown.Patient is still in the hospital with poor prognosis.The current nih and rankin scores are currently unknown.The device remains implanted, therefore, it is not available to be returned for analysis.A device history record (dhr) review and additional information are 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.Concomitant devices: 7mm angioguard rx, catalog number 701814rmc, lot number 35220785.

Manufacturer Narrative

Additional information was provided: the cause of the atypical findings in mri have not been diagnosed.Extensive evaluation of the abnormal leptomeningeal enhancement from brain mri has been pursued, including brain biopsy.Brain biopsy was "essentially negative".Neurology has followed the patient and "is comfortable with the diagnosis of neurosarcoidosis or cerebral vasculitis." the most recent interim summary says "concern for vasculitis or cns lymphoma versus neurological sarcoidosis.Brain biopsy and extensive laboratory workup as well as imaging workup was negative for these diagnoses." interim summaries indicate that the seizures are likely secondary to neurosarcoidosis/vasculitis.It is unknown how many seizures the patient has had.However, after the seizure, the patient has been largely unresponsive throughout hospitalization.The additional information that was recently obtained on the seizure does not meet the required criteria for medical device reporting as the information states that the event was likely secondary to neurosarcoidosis/vasculitis.There is no medical evidence of a causal relationship between the stent placed in the carotid artery and the patient developing lymphoma or sarcoidosis.Therefore, please note that as there is no alleged product failure and this file was inadvertently submitted as a complaint under the medical device reporting regulations.No further reports are forthcoming.

• 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: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3793311
• MDR Text Key: 4479680
• Report Number: 9616099-2014-00303
• 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: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 15852501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR