BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S.M.A.R.T. NITINOL STENT SYSTEM

    MDR report key: 3904473 · Received July 1, 2014

    Report

    Report Number
    9616099-2014-00434
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    October 13, 2003
    Report Date
    June 6, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: BUSH ET AL CAROTID (2003). ARTERY STENTING IN A COMMUNITY SETTING: EXPERIENCE OUTSIDE OF A CLINICAL TRIAL, 17, 629-634. PLEASE NOTE THAT THERE ON NO DEICE SPECIFICS AVAILABLE. THE LITERATURE PUBLICATION HAS BEEN ATTACHED TO THIS INITIAL MEDWATCH REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN A PUBLICATION, CAROTID ARTERY STENTING IN A COMMUNITY SETTING: EXPERIENCE OUTSIDE OF A CLINICAL TRIAL. ONE PATIENT UNDERGOING STAGED BILATERAL STENTING WITH A SMART STENT, DEVELOPED SEIZURES REQUIRING MEDICAL THERAPY AFTER THE FIRST PROCEDURE. HE REMAINED ON DILANTIN AND PHENOBARBITAL FOR 6 MONTHS AFTER BOTH CAROTID ARTERIES WERE REVASCULARIZED. THE SMART STENT WAS DEPLOYED VIA PERCUTANEOUS FEMORAL ARTERY ACCESS, WITH ANTICOAGULATION. THE STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER AVAILABLE; THEREFORE A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. AS WITH ANY INTERVENTIONAL PROCEDURE WHERE FOREIGN OBJECTS ARE INTRODUCED INTO THE PATIENTS VASCULATURE COMPLICATIONS CAN OCCUR. ONE POSSIBLE COMPLICATION OF BOTH CAROTID ENDARTERECTOMY AND CAROTID ANGIOPLASTY WITH STENTING INCLUDE, ALTHOUGH RARE, IS SEIZURES (BURSTS OF ABNORMAL ELECTRICAL SIGNALS THAT TEMPORARILY INTERRUPT NORMAL ELECTRICAL BRAIN FUNCTION). ONE POSSIBLE ETIOLOGY THAT IS CURRENTLY BEING INVESTIGATED IN THE LITERATURE IS HYPERPERFUSION, ALSO A WELL KNOWN POTENTIAL COMPLICATION OF THE CAROTID ARTERY STENTING PROCEDURE. EVIDENCE FROM OBSERVATIONAL STUDIES SUGGESTS THAT A NUMBER OF FACTORS ¿ ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE IN HYPERPERFUSION SYNDROME, 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. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PHARMACEUTICAL, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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.

    Description of Event or Problem · 1

    AS NOTED IN A PUBLICATION, CAROTID ARTERY STENTING IN A COMMUNITY SETTING: EXPERIENCE OUTSIDE OF A CLINICAL TRIAL. ONE PATIENT UNDERGOING STAGED BILATERAL STENTING WITH A SMART STENT, DEVELOPED SEIZURES REQUIRING MEDICAL THERAPY AFTER THE FIRST PROCEDURE. HE REMAINED ON DILANTIN AND PHENOBARBITAL FOR 6 MONTHS AFTER BOTH CAROTID ARTERIES WERE REVASCULARIZED. THE SMART STENTS WERE DEPLOYED VIA PERCUTANEOUS FEMORAL ARTERY ACCESS, WITH ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384893 S.M.A.R.T. NITINOL STENT SYSTEM SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R