BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE OTW NITINOL STENT

    MDR report key: 1140112 · Received August 28, 2008

    Report

    Report Number
    9616099-2008-02113
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    June 3, 2008
    Report Date
    August 5, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 13384986 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ZERO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. TRANSIENT HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CAROTID ARTERY STENT IMPLANTATION. THE PHYSICIAN ATTRIBUTED THESE REACTIONS TO THE BARO-RECEPTOR TRAUMA THAT IS INTRINSIC TO THE CAROTID ARTERY MANIPULATION DURING STENT IMPLANTATION. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THE PATIENT UNDERWENT CAROTID STENT IMPLANTATION AND EXPERIENCED HYPOTENSION. THE PATIENT WITH MEDICAL HISTORY INCLUDING (TIA) TRANSISCHEMIC ATTACK, HYPERTENSION AND DIABETES UNDERWENT AN INTERVENTION OF A LESION IN THE LEFT INTERNAL CAROTID ARTERY. THERE WAS MILD VESSEL CALCIFICATION BUT NO TORTUOSITY, AND THE RATE OF STENOSIS WAS 93%. AN ANGIOGUARD DEVICE WAS USED AND REMOVED WITHOUT ANY REPORTED DIFFICULTIES. AT THE END OF THE PROCEDURE, WHEN ALL OF THE DEVICES HAD BEEN REMOVED FROM THE PATIENT, THE PATIENT'S BLOOD PRESSURE DROPPED. VASOPRESSOR MEDICATIONS WERE ADMINISTERED WITH RAPID RECOVERY OF NORMAL BLOOD PRESSURE. ACCORDING TO THE PHYSICIAN, THERE WAS A POSSIBILITY THAT THESE SYMPTOMS WERE CAUSED BY CAROTID SINUS REFLEX BY THE STENT PLACEMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY FURTHER SEQUELAE. THE STENT REMAINS IMPLANTED, THUS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE OTW NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13384986

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention ANGIOGUARD XP: 603014MC