BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT¿ RP ENDOPROSTHESIS

    MDR report key: 3013041 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-02226
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS FULLY MOUNTED. A VISUAL AND TACTILE EXAMINATION OF THE SHAFT OF THE DEVICE NOTED THAT IT WAS SEVERELY KINKED AT 60MM DISTAL TO THE T-BAR CONNECTOR AND PARTIALLY BROKEN AT 25MM DISTAL TO THE T-BAR CONNECTOR. THE BREAK IS CONSISTENT WITH THE END OF THE STAINLESS STEEL SHAFT. DURING AN ATTEMPT TO FLUSH THE DEVICE IT WAS NOTED THAT LIQUID WAS LEAKING FROM WHERE THE SHAFT WAS PARTIALLY BROKEN. 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

    REPORTABLE BASED UPON ANALYSIS COMPLETED ON (B)(4) 2013 IT WAS REPORTABLE THAT DURING PREPARATION FOR A STENTING TREATMENT PROCEDURE A SHAFT LEAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ILIAC ARTERY (LIA). DURING PREPARATION, OUTSIDE OF THE PATIENT A 9X18X75MM 6F WALLSTENT RP WAS FLUSHED WITH HEPARINIZED SALINE. A LEAK WAS NOTED AT THE MID PORTION OF THE SHAFT. THE WALLSTENT RP WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS GOOD. ANALYSIS OF THE RETURNED DEVICE REVEALED A SHAFT BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115500 WALLSTENT¿ RP ENDOPROSTHESIS STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY M001712240 15221045

    Patients

    Seq Age Sex Outcome Treatment
    1