BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT¿ RP ENDOPROSTHESIS

    MDR report key: 6084630 · Received November 7, 2016

    Report

    Report Number
    2134265-2016-09783
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MAF
    PMA / PMN Number
    P940019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).  DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 DEPLOYMENT ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL OF THE UPPER ARM. A 6X46X75/ ILIAC 6F WALLSTENT RP ENDOPROSTHESIS WAS ADVANCED TO TREAT THE LESION. AS THE OUTER SHEATH WAS PULLED, THE STENT WAS DIFFICULT TO DEPLOY. THE PHYSICIAN SUSPECTED THAT THE OUTER SHEATH WAS BENT IN ACCORDION SHAPE AND CAUSED THE STENT DEPLOYMENT FAILURE. EVENTUALLY, THE STENT WAS ABLE TO BE DEPLOYED HOWEVER, IT DID NOT FULLY COVER THE TARGET LESION AND THE STENT DEPLOYED BY ITSELF. ANOTHER WALLSTENT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733000 WALLSTENT¿ RP ENDOPROSTHESIS STENT, CORONARY MAF BOSTON SCIENTIFIC - GALWAY M001712040 0018444837

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDEWIRE: RADIFOCUS| INFLATION DEVICE: EVEREST| INTRODUCER SHEATH: 6F