BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3904392 · Received July 1, 2014

    Report

    Report Number
    9616099-2014-00433
    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 DEVICE 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 EXPERIENCED A MINOR STROKE THAT OCCURRED 12 HOURS AFTER SMART STENTING. SHE WAS SYMPTOMATIC WITH SEVERE CORONARY ARTERY DISEASE AND HAD BEEN CONSIDERED INOPERABLE. THERE WAS NO INTRACRANIAL HEMORRHAGE ON CT SCAN AND HER SYMPTOMS, INCLUDING A FACIAL DROOP, DYSARTHRIA, AND CONTRALATERAL HEMIPARESIS, HAD GREATLY IMPROVED AT DISCHARGE (HOSPITAL DAY 7). THE SMART STENT WAS DEPLOYED VIA PERCUTANEOUS FEMORAL ARTERY ACCESS, WITH ANTICOAGULATION. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. 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. 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.

    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 EXPERIENCED A MINOR STROKE THAT OCCURRED 12 HOURS AFTER SMART STENTING. SHE WAS SYMPTOMATIC WITH SEVERE CORONARY ARTERY DISEASE AND HAD BEEN CONSIDERED INOPERABLE. THERE WAS NO INTRACRANIAL HEMORRHAGE ON CT SCAN AND HER SYMPTOMS, INCLUDING A FACIAL DROOP, DYSARTHRIA, AND CONTRALATERAL HEMIPARESIS, HAD GREATLY IMPROVED AT DISCHARGE (HOSPITAL DAY 7). THE SMART STENT WAS DEPLOYED VIA PERCUTANEOUS FEMORAL ARTERY ACCESS, WITH ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384787 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 Hospitalization