BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1885079 · Received October 20, 2010

    Report

    Report Number
    2953200-2010-02007
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - CAUSE OF LEAK CANNOT BE DETERMINED; FAILURE TO DELIVER THE STENT; NEGATIVE PREPARATION INSTRUCTED TO BE PERFORMED IN-VITRO AND WITH A SYRINGE. CONCLUSIONS - CAUSE OF LEAK CANNOT BE DETERMINED. DEVICE EVALUATION: THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATION. THE FIRST DISTAL AND FIRST PROXIMAL STENT SEGMENTS WERE FLARED. THE DISTAL AND PROXIMAL PILLOWS WERE PARTIALLY INFLATED. THE LAST PROXIMAL SEGMENT WAS SLIGHTLY FLARED. A 2MM LONGITUDINAL TEAR ON THE PROXIMAL PILLOW CONFIRMED THE PRESENCE OF A BALLOON LEAK.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A 3.0MM DIAMETER X 24MM LENGTH ENDEAVOR RESOLUTE RAPID EXCHANGE (RX) DRUG-ELUTING STENT. THE PHYSICIAN INSERTED THE STENT DELIVERY SYSTEM INTO THE GUIDING CATHETER. NEGATIVE PRESSURE WAS THEN APPLIED TO THE DEVICE TO INSPECT FOR ABNORMALITIES. AT THIS STAGE, THE PHYSICIAN NOTED SOME BLOOD COMING OUT OF THE DELIVERY SYSTEM. THE PHYSICIAN RETRIEVED THE STENT FOR INSPECTION. UPON REMOVAL, IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT'S BALLOON WAS DAMAGED. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0002534466

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK