BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1852261 · Received October 4, 2010

    Report

    Report Number
    9616099-2010-00745
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 21, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13452173 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. TIA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. TIA IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY COLLECT IN THE EMBOLIC PROTECTION DEVICE POTENTIALLY DISRUPTING PERFUSION. 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.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED VIA THE (B)(4) STUDY DATABASE INDICATED THAT HOURS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A TIA. THE TIA RESOLVED COMPLETELY IN LESS THAN 24 HOURS WITHOUT TREATMENT PER THE STUDY COORDINATOR. NO RESIDUAL SYMPTOMS REMAINED. THE EVENT WAS NOTED TO BE RELATED TO THE PRECISE STENT IMPLANTED. THE ADJUDICATION MINUTES RECEIVED (B)(4) 2010 FOR THIS EVENT AGREE WITH THE PREVIOUS DIAGNOSIS OF TIA LASTING < 24 HOURS WITH FULL RECOVERY. HOWEVER, NEW INFORMATION NOTES THAT THIS EVENT WAS TREATED WITH IV FLUIDS. AS SUCH, THIS EVENT HAS BEEN CHANGED TO A REPORTABLE EVENT. IT WAS ALSO NOTED THAT THERE WAS A SECOND SIMILAR EVENT LATER THAT EVENING AND THAT THE PATIENT WAS GIVEN A BOLUS OF ABCIXIMAB. THIS WAS FOLLOWED BY A 12-HOUR WEIGHT-BASED INFUSION AND THEN A HEPARIN INFUSION OVERNIGHT. THERE WERE NO ADDITIONAL EPISODES REPORTED. THIS SECOND EVENT OF TIA HAS ALSO BEEN ADDED TO THE FILE AS A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13452173

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention