BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 2070458 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01503
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT HAD MOVED OFF THE BALLOON MATERIAL PROXIMALLY ONTO THE SHAFT OF THE DEVICE. IT WAS NOTED THAT THE BALLOON MATERIAL HAD BEEN INFLATED. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL NOTED CRIMP MARKS WHERE THE STENT HAD BEEN CRIMPED IN THE CORRECT POSITION. A TACTILE EXAMINATION OF THE SHAFT OF THE RETURNED DEVICE NOTED NO ANOMALIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RENAL ARTERY. WHEN THE PHYSICIAN WAS PREPPRING THE 6.0X20X135CM EXPRESS VASCULAR LD STENT THE STENT DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6.0X20X135CM EXPRESS VASCULAR LD STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE RENAL ARTERY. WHEN THE PHYSICIAN WAS PREPARING THE 6.0X20X135CM EXPRESS VASCULAR LD STENT THE STENT DISLODGED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 6.0X20X135CM EXPRESS VASCULAR LD STENT. NO COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162620130 13042084

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR