BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM

    MDR report key: 1982379 · Received February 9, 2011

    Report

    Report Number
    2134265-2011-00125
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE DID NOT REVEAL ANY DAMAGE TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED AROUND THE SHAFT. THE STENT WAS NOT ON THE BALLOON AT THE TIME OF RETURN. A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED IS VISIBLE ON THE BALLOON MATERIAL. VISUAL AND MICROSCOPIC EXAMINATION OF THE STENT OBSERVED THAT SOME OF THE STRUTS ON THE STENT WERE PUSHED APART. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. THE 9.0X30X75CM EXPRESS VASCULAR STENT SYSTEM WAS ADVANCED TO THE LESION FOR DIRECT STENTING. WHILE ATTEMPTING TO DEPLOY THE STENT, IT DISLODGED FROM THE SDS. THE STENT WAS SUCCESSFULLY REMOVED UTILIZING A SNARING DEVICE. PRE-DILATATION WAS THEN PERFORMED WITH A 5MM BALLOON AND A 9.0X37MM EXPRESS LD STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC ARTERY. THE 9.0X30X75CM EXPRESS VASCULAR STENT SYSTEM WAS ADVANCED TO THE LESION FOR DIRECT STENTING. WHILE ATTEMPTING TO DEPLOY THE STENT, IT DISLODGED FROM THE SDS. THE STENT WAS SUCCESSFULLY REMOVED UTILIZING A SNARING DEVICE. PRE-DILATATION WAS THEN PERFORMED WITH A 5MM BALLOON AND A 9.0X37MM EXPRESS LD STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED 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 H74938162920750 13105179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6FR INTRODUCER SHEATH