BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 2992692 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01165
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    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

    DEVICE EVALUATED BY MANUFACTURER: INITIAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE STENT HAD BEEN DEPLOYED FROM THE BALLOON MATERIAL. THE BALLOON MATERIAL WAS FULLY DEFLATED BUT NOT CORRECTLY WRAPPED. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED EVIDENCE OF CRIMP MARKS INDICATING THAT THE STENT HAD BEEN CRIMPED CORRECTLY ONTO THE BALLOON. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED THAT IT WAS FLATTENED FOR A DISTANCE OF 29MM AT APPROXIMATELY 320MM DISTAL TO THE STRAIN RELIEF. 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).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH A 6F NON BSC SHEATH VIA THE LEFT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUBCLAVIAN ARTERY. DURING ADVANCEMENT OF A 7.0X40X135 CM EXPRESS LD VASCULAR STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS ENCOUNTERED AND THE DEVICE COULD NOT CROSS THE TARGET LESION. THE EXPRESS LD SDS WAS UNABLE TO RETRACT INTO THE 6FR SHEATH. AN ATTEMPT TO REMOVE THE EXPRESS LD SDS AND THE 6FR SHEATH TOGETHER AS ONE UNIT WAS UNSUCCESSFUL. IT WAS NOTED THAT THE EXPRESS LD STENT HAD MOVED ON THE DELIVERY BALLOON. THE STENT WAS IMPLANTED AT THE EXTERNAL ILIAC ARTERY. A KINK WAS NOTED IN THE MID PORTION OF THE EXPRESS LD SDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS 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, DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH A 6F NON BSC SHEATH VIA THE LEFT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT SUBCLAVIAN ARTERY. DURING ADVANCEMENT OF A 7.0X40X135 CM EXPRESS LD VASCULAR STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS ENCOUNTERED AND THE DEVICE COULD NOT CROSS THE TARGET LESION. THE EXPRESS LD SDS WAS UNABLE TO RETRACT INTO THE 6FR SHEATH. AN ATTEMPT TO REMOVE THE EXPRESS LD SDS AND THE 6FR SHEATH TOGETHER AS ONE UNIT WAS UNSUCCESSFUL. IT WAS NOTED THAT THE EXPRESS LD STENT HAD MOVED ON THE DELIVERY BALLOON. THE STENT WAS IMPLANTED AT THE EXTERNAL ILIAC ARTERY. A KINK WAS NOTED IN THE MID PORTION OF THE EXPRESS LD SDS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS 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
    97109 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162740130 15593964

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTRODUCER SHEATH, 6FR DESTINATION| BALLOON CATHETER, ULTRABIRTTH 5MM-40MM