BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 2071051 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01541
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL AND TACTILE EXAMINATION OF THE DEVICE REVEALED THAT THE STENT HAD MOVED 24MM DISTALLY ON THE BALLOON. THE PROXIMAL SECTION OF THE BALLOON WAS FOLDED AND A CLEAR IMPRESSION OF WHERE THE STENT WAS ORIGINALLY CRIMPED WAS VISIBLE ON THE BALLOON MATERIAL. VISUAL EXAMINATION OF THE STENT NOTED THAT SOME OF THE STRUTS ON THE PROXIMAL END OF THE STENT WERE MISALIGNED AND SOME OF THE STRUTS ON THE SIXTH ROW FROM THE DISTAL END OF THE STENT WERE LIFTED UP. THE DISTAL END OF THE STENT WAS LOCATED 12MM OVER THE DISTAL TIP. NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. IT IS NOT POSSIBLE TO DETERMINE WHEN THE STENT MOVED ON THE BALLOON, AS THE DEVICE WAS NOT RECEIVED INSIDE ITS PACKAGING HOOP. FROM THE CONDITION OF THE STENT AND THE BALLOON IT WAS NOT POSSIBLE TO CHECK THE PROFILE MEASUREMENTS. 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A PERIPHERAL STENTING TREATMENT PROCEDURE THE STENT WAS LOOSE ON THE DELIVERY SYSTEM. THE TARGET LESION WAS LOCATED IN THE ILIAC. WHILE UNPACKING A EXPRESS-B-I LD, PMTD, 7.0X40X75CM STENT, IT WAS NOTICED THAT THE STENT WOULD SLIDE BACK AND FORTH ALONG THE DELIVERY SYSTEM. THE DEVICE DID NOT CONTACT THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR A PERIPHERAL STENTING TREATMENT PROCEDURE, THE STENT WAS LOOSE ON THE DELIVERY SYSTEM. THE TARGET LESION WAS LOCATED IN THE ILIAC. WHILE UNPACKING A EXPRESS-B-I LD, PMTD, 7.0X40X75CM STENT, IT WAS NOTICED THAT THE STENT WOULD SLIDE BACK AND FORTH ALONG THE DELIVERY SYSTEM. THE DEVICE DID NOT CONTACT THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046740750 0013710356

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR